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

Catalog Number	PXT231212
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® excluder® endoprosthesis instructions for use (ifu) states, potential adverse events that may occur and/or require intervention include, but are not limited to endoleak.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) 2007, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2018, this patient underwent reintervention and was implanted with additional gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2019, it was reported that follow-up imaging performed on (b)(6) 2019 determined the patient had a type ii endoleak.There is no reintervention scheduled for the patient at this time.
Event or Problem Description
On (b)(6) 2019, the patient underwent reintervention and two additional contralateral leg components was implanted along with a palmaz stent to better support the proximal trunk and seal zone.

• 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: 9323456
• Report Number: 2017233-2019-01140
• Device Sequence Number: 410757
• Product Code: MIH
• UDI-Device Identifier: 00733132610099
• UDI-Public: 00733132610099
• 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: 2007
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 06/30/2008
• Device Catalogue Number: PXT231212
• Device Lot Number: 03806994
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: 80 YR