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

Model Number	PXT281418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report also includes device (b)(4).
Event or Problem Description
On (b)(6) 2006, the patient was treated for an abdominal aortic aneurysm.The physician implanted two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, the patient reported emergently with a type ia endoleak and rupture.The patient was treated with a non-gore device.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications; h6: code 22 ¿ according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.

• 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: 10489192
• Report Number: 2017233-2020-01209
• Device Sequence Number: 17167169
• Product Code: MIH
• UDI-Device Identifier: 00733132610327
• UDI-Public: 00733132610327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2009
• Device Model Number: PXT281418
• Device Catalogue Number: PXT281418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR