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

Catalog Number	RLT231416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include but are not limited to: aspirin, (b)(6).
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure with a small type ii identified at the conclusion of the procedure.The physician chose to monitor the patient.On (b)(6) 2019, follow-up computed tomography (ct) showed the type ii persisted.On (b)(6) 2019, the patient underwent reintervention and coil embolization of a lumbar artery was performed.Conclusion ct showed the type ii persisted very slightly.The patient tolerated the procedure.On (b)(6) 2019, follow-up ct showed the type ii showed a robust type ii endoleak, no enlargement of the aneurysm was seen.On (b)(6) 2019, the patient underwent reintervention and coil embolization above the area previously coiled was performed.The type ii endoleak as resolved and no enlargement of the aneurysm was reported.The patient tolerated the procedure.Images were provided to gore and showed the following: images provided appear to be post lumbar embolization.There appears to be contrast outside of the implanted device on the arterial phase.There appears to be patent lumbars present.There appears to be an endoleak of indeterminate origin.
Additional Manufacturer Narrative
B3: additional/corrected information.

• 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: 9235824
• Report Number: 3007284313-2019-00323
• Device Sequence Number: 388015
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 03/20/2021
• Device Catalogue Number: RLT231416
• Device Lot Number: 17924706
• 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: 10/24/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: 83 YR
• Patient Weight: 83