FDA Adverse Event Injury Summary report: N

GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 2801435 · Received October 11, 2012

Report

Report Number: 2017233-2012-00695
Event Type: Injury
Date Received: October 11, 2012
Date of Event: April 6, 2011
Report Date: September 13, 2012
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. "USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES."

Description of Event or Problem · 1

ON (B)(6) 2011, THE PT UNDERWENT ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM. THERE WAS A TYPE II ENDOLEAK ORIGINATING FROM THE RIGHT BRANCH OF THE INTERNAL ILIAC ARTERY (RIIA) AT THE CONCLUSION OF THE PROCEDURE. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2012, THE PT UNDERWENT SUCCESSFUL PERCUTANEOUS EMBOLIZATION, VIA THE RIGHT INTERNAL ILIAC ARTERY. THE ACUTE ANGULATION AT THE ORIGIN OF THE PT'S RIGHT ILIO LUMBAR FEEDING VESSEL PREVENTED STABLE EMBOLIZATION. ON (B)(6) 2012, THE PT UNDERWENT REINTERVENTION FOR THE PREVIOUSLY IDENTIFIED ENDOLEAK. THE LUMBAR ARTERY WAS COILED VERY CLOSE TO THE SAC WITH AXIUM COILS. A GOOD ANGIOGRAPHIC OUTCOME WAS ACHIEVED.

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		7805270

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Hospitalization\| O\| R	PXC161000/8876600\| PXC161200/8882099\| PXC141000/8870877