FDA Adverse Event Injury Summary report: N

GORE EXCLUDER AAA ENDOPROSTHESIS

MDR report key: 2833120 · Received November 6, 2012

Report

Report Number: 2017233-2012-00748
Event Type: Injury
Date Received: November 6, 2012
Date of Event: October 4, 2012
Report Date: October 10, 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

PLEASE NOTE ADD'L DEVICE RELATED TO THIS EVENT: (B)(4). RESULT - A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECS. CONCLUSION - 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. ADDITIONALLY, ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, PTS SHOULD BE COUNSELED AS TO THE POSSIBILITY FOR SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER-BASED AND OPEN SURGICAL CONVERSION.

Description of Event or Problem · 1

ON (B)(6) 2011, THE PT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS WITH THE GORE C3 DELIVERY SYSTEM. ON (B)(6) 2012, THE PT HAD COMPUTED TOMOGRAPHY ANGIOGRAPHY THAT DETERMINED A TYPE II ENDOLEAK WAS PRESENT. ON (B)(6) 2012, THE PT UNDERWENT COIL EMBOLIZATION OF A LUMBAR ARTERY WITH EXCELLENT RESULTS. NO FURTHER PERFUSION OF THE SAC WAS SEEN. NO ENLARGEMENT OF THE ANEURYSM WAS REPORTED. THE PT TOLERATED THE PROCEDURE.

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		9472921

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Hospitalization\| L\| O\| R