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

Model Number	PXC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore(r) excluder(r) aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2009, this patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore(r) excluder(r) aaa endoprosthesis contralateral leg component.The patient had a persistent type 2 endoleak and had underwent intervention whereby lumbar arteries were excluded via surgery and coil embolization.On (b)(6) 2021 the patient presented with no evidence of type 1 or type1b endoleaks, however aneurysm enlargement was noted.The aneurysm enlarged to 8cm.The physician decided to explant the gore(r) excluder(r) aaa endoprosthesis contralateral leg component.
Additional Manufacturer Narrative
G1.Manufacturing site name and address: medical sunnyvale 1327 orleans dr sunnyvale, ca 94089.

• 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: 11267830
• Report Number: 3007284313-2021-01237
• Device Sequence Number: 3415949
• Product Code: MIH
• UDI-Device Identifier: 00733132609925
• UDI-Public: 00733132609925
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 07/31/2012
• Device Model Number: PXC121200
• Device Catalogue Number: PXC121200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: Required Intervention
• Patient Age: 75 YR