FDA Adverse Event Death Summary report: N

GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 1843569 · Received September 20, 2010

Report

Report Number: 2017233-2010-00408
Event Type: Death
Date Received: September 20, 2010
Date of Event: August 30, 2010
Report Date: September 20, 2010
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED/EXPLANTED: (B)(4)/PXT281412.

Description of Event or Problem · 1

ON (B)(6) 2010, THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. AFTER IMPLANTING A TRUNK-IPSILATERAL LEG COMPONENT, THE PHYSICIAN TRIED TO CANNULATE; HOWEVER, AFTER SEVERAL ATTEMPTS WAS UNABLE TO AND PERFORMED AN UNPLANNED AORTO-UNI-ILIAC, USING A SECOND TRUNK-IPSILATERAL LEG COMPONENT. WHILE BALLOONING THE PROXIMAL END OF THE FIRST IMPLANTED TRUNK-IPSILATERAL LEG COMPONENT WITH A QXMEDICAL BALLOON, THE BALLOON WAS OVERINFLATED AND THE PATIENT'S AORTA DISSECTED. THE PATIENT WAS CONVERTED TO OPEN REPAIR. BOTH GORE EXCLUDER AAA ENDOPROSTHESIS WERE EXPLANTED AND DISCARDED. ON (B)(6) 2010, THE PATIENT'S BOWEL BECAME ISCHEMIC. LATER THAT EVENING, THE PATIENT'S KIDNEYS BEGAN TO SHUT DOWN. THE PATIENT EXPIRED ON (B)(6) 2010. THE PHYSICIAN STATED THE CAUSE OF DEATH TO BE ISCHEMIC BOWEL, KIDNEY FAILURE AND CARDIOMYOPATHY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GORE EXCLUDER AAA ENDOPROSTHESIS	MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES	WLG325	7799062

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Death