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

Catalog Number	RMT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: aspirin, lipitor, vitamin d3, toprol-xl, effient, and altace.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak.Images dated (b)(6) 2019, were sent to gore imaging services for evaluation.Per the evaluation the length from the lowest renal artery to the proximal end of the implanted trunk appears to be 14.4 mm.Migration of the trunk and growth of the aneurysm cannot be confirmed as only one time point was provided for evaluation.There does not appear to be any visible contrast outside implanted devices on images provided for evaluation.
Event or Problem Description
On (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.The physician office stated that the date the event was identified was on (b)(6) 2019 (these images are not available).On (b)(6) 2019, the physician reintervened to treat an enlarging abdominal aortic aneurysm secondary to distal migration of previous implanted aortic stent graft with a probable type i endoleak.The physician implanted two gore® excluder® aaa aortic extender endoprostheses, the endoleak was resolved.The patient tolerated the procedure.

• 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: 8992482
• Report Number: 2017233-2019-00844
• Device Sequence Number: 19678172
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: 04/30/2017
• Device Catalogue Number: RMT281414
• Device Lot Number: 12672416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2019
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75