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

Catalog Number	PLC121400
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Instructions for use (ifu) states, the gore® excluder® aaa endoprosthesis provides endovascular treatment of infrarenal abdominal aortic aneurysms (aaas).The gore® excluder® aaa endoprosthesis is comprised of two components, the trunk-ipsilateral leg endoprosthesis (trunk) and the contralateral leg endoprosthesis.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, this patient underwent treatment for a right common iliac artery aneurysm and was implanted with a gore® excluder contralateral leg component in the right common/external iliac artery.The device was landed distal to the aortic bifurcation; resulting in a type 1a endoleak.On (b)(6) 2019,an additional contralateral leg component was implanted to extend coverage proximally and resolved the endoleak.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9267061
• Report Number: 3013164176-2019-00143
• Device Sequence Number: 19394225
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 08/08/2022
• Device Catalogue Number: PLC121400
• Device Lot Number: 20951055
• 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: 11/01/2019
• 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; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 52