GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 2921939 · Received January 11, 2013

Report

Report Number: 2953161-2013-00010
Event Type: Injury
Date Received: January 11, 2013
Date of Event: January 4, 2013
Report Date: January 4, 2013
Manufacturer: W. L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

Description of Event or Problem · 1

ON (B)(6) 2013, THE PT WAS IMPLANTED WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESES. AT THE TIME OF THE POST-DEPLOYMENT ANGIOGRAM, IT WAS NOTED THAT THERE MAY BE A SLIGHT DISSECTION OR PLAQUE, DISTAL TO THE LEFT RENAL ARTERY. NO ENDOLEAK WAS PRESENT, AND THE PT TOLERATED THE PROCEDURE WITHOUT INCIDENT. APPROX 15 MINS POST-PROCEDURE, THE PT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE. THE PT WAS IMMEDIATELY TAKEN BACK TO THE OPERATING ROOM, WHERE AN EMERGENCY LAPAROTOMY WAS PERFORMED. AFTER CROSS CLAMPING THE INFRARENAL PROXIMAL AORTA, IT WAS REPORTED THAT THE PROXIMAL EDGE OF THE DEVICE COULD BE SEEN PROTRUDING THROUGH THE AREA NOTED ON THE POST-DEPLOYMENT ANGIOGRAM. THE EXCLUDER STENT-GRAFT SYSTEM WAS IMMEDIATELY EXCISED. A DACRON TUBE GRAFT WAS PLACED USING AN END TO END ANASTOMOSIS. THE ANEURYSM WAS SUCCESSFULLY REPAIRED, AND THE PT TOLERATED THE PROCEDURE. THE PHYSICIAN INDICATED THE EVENT WAS NOT CAUSED BY THE GORE DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
19247	GORE EXCLUDER AAA ENDOPROSTHESIS	MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W. L. GORE & ASSOCIATES		9006510

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Hospitalization\| R	POTASSIUM\| CHLORTHALIDONE\| ASPIRIN\| VITAMIN D3\| VITAMIN B12