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

Model Number	PLL161007
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the review of the manufacturing paperwork verified that the lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use warns against covering significant vessels.Also, according to the ifu, potential adverse events that may occur and require intervention include improper component placement and occlusion of the native vessel.
Event or Problem Description
The field sales associate reported the following information: on (b)(6) 2021, the patient had an evar to repair an abdominal aortic aneurysm.During the procedure the decision was made to intentionally cover the left hypogastric artery.After the evar procedure, the patient developed colitis and had surgery on (b)(6) 2021, to remove part of the colon.The patient is recovering well after the secondary procedure.
Additional Manufacturer Narrative
Updated section g1 to reflect the correct manufacturing site information.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12618202
• Report Number: 3007284313-2021-01619
• Device Sequence Number: 14320968
• Product Code: MIH
• UDI-Device Identifier: 00733132618811
• UDI-Public: 00733132618811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 05/12/2024
• Device Model Number: PLL161007
• Device Catalogue Number: PLL161007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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