MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PXC201200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: xalatan, plavix, oscal, prinivil, lipitor, actos, tylenol, albuterol, lasix and tessalon.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include aneurysm rupture.The possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular procedure.
Event or Problem Description
On (b)(6) 2006, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm (aaa).The patient tolerated the procedure.It was reported that on (b)(6) 2019, the patient presented to the emergency room with a ruptured aaa in the left common iliac artery.Images revealed the contralateral leg endoprosthesis (pxc201200/04595219) was free floating in the aneurysm sac and had migrated out of the iliac artery, which was also aneurysmal at time of implant.The physician chose to embolize the left internal iliac artery and extend with a contralateral leg endoprosthesis (plc121400/20227629) into the left external common iliac artery.The endoleak was resolved and the patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8847384
• Report Number: 2017233-2019-00586
• Device Sequence Number: 16206716
• Product Code: MIH
• UDI-Device Identifier: 00733132610044
• UDI-Public: 00733132610044
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: PXC201200
• Device Lot Number: 04595219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 96