FDA Adverse Event Injury Summary report: N

GORE® EXCLUDER® AAA ENDOPROSTHESIS

MDR report key: 4823151 · Received June 6, 2015

Report

Report Number: 2017233-2015-00331
Event Type: Injury
Date Received: June 6, 2015
Date of Event: May 8, 2015
Report Date: August 18, 2015
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO IMPROPER DEVICE PLACEMENT. MANUFACTURING EVALUATION PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ON (B)(6) 2015, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, THE IPSILATERAL LEG OF THE RMT231418 COVERED THE LEFT INTERNAL ILIAC ARTERY (LIIA) UNINTENTIONALLY. IT WAS REPORTED THAT THE TREATMENT LENGTH WAS 15-16CM. THE PHYSICIAN REPORTEDLY SELECTED RMT231418 AND PLANNED TO PUSH UP THE IPSILATERAL LEG TO LAND JUST ABOVE THE LIIA THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED. NO HEALTH HAZARD DUE TO THE UNINTENTIONAL COVERAGE OF THE LIIA HAS BEEN REPORTED. THE PATIENT¿S WEIGHT, DOB AND MEDICAL HISTORY WERE NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
366824	GORE® EXCLUDER® AAA ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES		13266811

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Other