Evidence is suggesting that the device nearly always breaks at the exact same place in the catheter leading to significant neurological injury & sometimes death
SANTA BARBARA, CA, UNITED STATES, December 17, 2020 /EINPresswire.com/ — “The Penumbra Jet 7 Reperfusion Catheter used for revascularization of large vessel cerebral strokes is defective and unsafe. It was voluntarily recalled but too late for too many injured patients,” states Greg Vigna, MD, JD.
The Vigna Law Firm, a national pharmaceutical injury law firm and neurological injury law firm is investigating injuries and deaths caused by the Jet 7 Reperfusion Catheter produced by Penumbra, Inc
Greg Vigna, MD, JD, practicing physician in Physical Medicine and Rehabilitation, national pharmaceutical injury attorney, and Certified Life Care Planner states, “Clearly, patients again were burned by the 510(k) fast track clearance procedure by a company who did not perform necessary testing of safety for their device. Clearly, Punumbra Inc.’s senior management failed to provide a timely warning that properly conveyed the magnitude of the risks to interventional radiologist and neurosurgeons at a time they knew there was a structural defect in the catheter. Evidence is suggesting that the device nearly always breaks at the exact same place in the catheter leading to significant neurological injury and sometimes death. In addition, the device has issues with uncontrolled ballooning which results in arterial rupture leading to catastrophic cerebral hemorrhage.”
Dr. Vigna adds, “We saw the same thing in the IVC litigation that safety signals were ignored by defendant manufacturers and when warning was finally given by Penumbra Inc. to physicians it was deceptive in that it appeared to be a routine communications of the dangers of catheters in general and did not specifically state the number of injuries and deaths and the presence of a common failure mode of the device that suggests a structural flaw.”
Dr. Vigna concludes, “In stroke management the penumbra refers to the brain in the vascular territory of an occluded blood vessel that is at risk of permanent cellular death if revascularization and blood supply is not regained is not timely fashion. It will not be difficult to determine how much brain was permanently damaged and the function that was lost as a result of this defective device. I do this all the time in failure to diagnose and treat stroke malpractice cases. This time we have a defective catheter and an injured patient who many times will require life-time attendant care for the injuries sustained.”
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome. He has clients with these diagnoses filed around the country with leading pharmaceutical injury lawyers. Other areas of focus are catastrophic neurological injury including failure to diagnose stroke and personal injury cases involving spinal cord injury, brachial plexus injury, and traumatic brain injury.
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