MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT231416
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/ or require intervention include, but are not limited to endoleak and component migration.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent treatment of an abdominal aortic aneurysm and a left internal iliac aneurysm with gore® excluder® aaa and iliac branch endoprostheses.The procedure was completed and final angio showed no presence of leak.On (b)(6) 2020 a follow-up cta scan showed a leak into the aneurysm.Reportedly the trunk-ipsilateral leg component migrated distally and/or potentially infolded.Options including placement of an extension cuff, relining and endo anchor placement were discussed with the gore fsa.The gore fsa offered to support the reintervention, but the physician declined.The patient outcome is unknown.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent treatment of an abdominal aortic aneurysm and a left internal iliac aneurysm with gore® excluder® aaa and iliac branch endoprostheses.The procedure was completed and final angio showed no presence of leak.On (b)(6) 2020 a reintervention took place whereby a medtronic aortic extender was implanted which resolved the endoleak.Reportedly the medtronic representative stated there did not appear to be infolding in the gore device, but rather it had just slipped down, causing the type ia endoleak.
Additional Manufacturer Narrative
H.6.Conclusion code 1: 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and component migration.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9922267
• Report Number: 3007284313-2020-00093
• Device Sequence Number: 14235668
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 06/28/2022
• Device Model Number: RLT231416
• Device Catalogue Number: RLT231416
• Device Lot Number: 20779607
• 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; Not provided
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/08/2020; 05/04/2020
• 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: 76 YR