Penumbra JET 7 Xtra Flex Hemorrhagic Stroke Catheter: Who’s Affected?
Did you or a loved one suffer a hemorrhagic stroke, which resulted in a blood clot that required operation?
Did you suffer from complications as a result of the defective catheter? Did a loved one die in a procedure involving the Penumbra catheter?
On Dec. 15, the FDA announced that Penumbra, Inc. issued an “urgent recall” of their JET 7 Xtra Flex catheter, most commonly used in thrombectomy procedures where surgeons remove blood clots from the arteries in the brain following a stroke.
Although the device has only been on the market since mid-2019, the FDA MAUDE database has already received approximately 18 reports of death associated with the device. In many of these reports, the tip of the catheter reportedly broke in surgery, causing complications such as vessel ruptures and eventual patient death.
What is the Penumbra Catheter?
Those who have suffered hemorrhagic strokes in the summer of 2019 may have had a surgery in which the recalled Penumbra JET 7 Xtra Flex Catheter was used.
According to Penumbra, Inc.’s website, the Penumbra JET 7 Reperfusion Catheter, which was cleared to market in June 2019, is a type of catheter designed for use in surgery for patients who have suffered a stroke.
A hemorrhagic stroke occurs when weakened blood vessels burst, causing blood to bleed into the brain, which damages brain cells. As a result, those who have suffered hemorrhagic strokes may find that the damaged areas of their brains are unable to function normally.
Revascularization can be done through the injection of an IV drug to destroy the clot or through the physical removal of the clot.
Penumbra’s reperfusion catheter is used by many surgeons in thrombectomy procedures when removing blood clots from the veins and arteries of their patients. During an imaging-guided procedure, a surgeon can insert the Penumbra catheter into the artery at the groin or wrist. The catheter can then be guided up the body to the artery which is blocked in the brain. Once the clot is secured, the catheter system reportedly uses suction to remove the clot and restore blood flow.
However, MAUDE database reports have reflected that the use of the Penumbra JET 7 Reperfusion Catheter during surgery has resulted in over a dozen deaths and over 50 injuries, challenging its reputation as a “modern medical legend.”
Is Penumbra, Inc.’s Catheter Safe?
As of Oct. 31, 2020, there have been 18 death reports involving the Penumbra filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database.
In several reports, arterial ruptures led to patient deaths. In some of these cases, the rupture occurred in the internal carotid artery, which supplies blood to the brain and eyes. Certain reported ruptures were associated with damage to the distal tip.
In one early report from September 2019, a patient died after the tip of the Penumbra catheter broke off inside the body during the revascularization procedure. When the catheter was removed, the doctor noted that the coils at the tip of the device were “unwound” and “frayed.”
A more recent report involved the death of a COVID-19 patient who had pneumonia from the virus and was subjected to the use of the defective Penumbra catheter in surgery. During this patient’s procedure, the tip of the Penumbra catheter reportedly fractured. The procedure ended upon discovery of the damaged catheter, and the COVID-19 patient later succumbed to “complications of the stroke and intracranial pressure.”
Many MAUDE reports tell a similar story: during surgery, the tip of the Penumbra catheter may break. This could lead to significant complications including vessel ruptures, hemorrhaging, and death.
MAUDE also reflects over 40 reports of injury during surgeries involving the defective Penumbra catheter.
In July 2020, a patient suffered injury after the surgeon noticed a carotid-cavernous sinus fistula (CCF), which occurs typically due to traumatic causes. The report specifically notes that “[t]he ccf was reported to be related to the jet7.”
A similar injury was reported in June 2020 whereby the patient suffered a CCF. The report read that “[t]he carotid cavernous fistula was reported to be related to the jet7.”
In a shocking report, one surgeon attempted to remove the Penumbra catheter and reported that “upon removal of the jet7, the patient’s head turned as if reacting to pain.” The report ends by stating that the medical status of said patient remains unknown.
Many of these and similar reports can be found in the MAUDE database.
Has There Been a Penumbra JET 7 Xtra Flex Catheter Recall?
On Dec. 15, Penumbra, Inc. issued an urgent voluntary recall of their Penumbra JET 7 Extra Flex catheter.
This came a little over a month after Gabriel Grego, managing partner at Quintessential Capital Management, published a short thesis calling the Penumbra Jet 7 “unsafe and unmarketable.”
This would not be Penumbra’s first defective medical device PR nightmare.
In 2007, there was a recall of Penumbra’s revascularization device. Penumbra recalled their Penumbra 3D Revascularization device due to concerns that the device’s delivery wire could break during use—leaving fractured pieces of wire in a patient’s brain.
Penumbra’s recent recall of the JET 7 Xtra Flex catheter came weeks after the press noted that the Alameda-based company had been failing to take responsibility for their defective productreportedly issued a “Notification to Healthcare Providers” in response to the breaking news.
In their letter, rather than owning the defect, Penumbra, Inc. warned physicians of the risk for tip rupture when contrast is injected through the catheter, and instructs surgeons not to use the catheter for this purpose but to instead inject contrast media through a guide catheter.
“JET7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices,” the Penumbra healthcare provider notification explains, and further notes that the “[d]istal tip expansion or rupture may cause vessel damage and subsequent patient injury or death.”
READ MORE: Jet 7 Xtra Flex Stroke Catheter Injuries
Can I Join A Penumbra Catheter Lawsuit Investigation?
Since its release in 2019, Penumbra, Inc.’s catheter—the JET 7 Xtra Flex—has allegedly resulted in 18 deaths and almost 50 reported injuries entered into the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
The Foundation for Financial Journalism demands that Penumbra, Inc. “be forced to address in more substantial terms than the July 27 release” in light of the growing list of MAUDE reports regarding safety risks of the defective Penumbra catheter.
Consequently, if Penumbra has indeed entered a device with known safety defects into the market and continues to sell it despite troubling reports, they may be legally liable for the injuries and deaths that resulted from the catheter’s use.
If you or a loved one suffered a hemorrhagic stroke AND the Penumbra JET 7 Xtra Flex catheter was used during a procedure after May 2019, you may be eligible to join this Penumbra Catheter Defective Product lawsuit investigation.
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