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

Model Number	RMT261412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that on (b)(6) 2010, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2019, an aneurysm of the left common iliac artery was identified.The aneurysm was treated with an extension of the previously implanted gore® excluder® trunk-ipsilateral leg endoprosthesis (rlt) on (b)(6) 2020.The patient tolerated the procedure.
Event or Problem Description
It was reported that on (b)(6) 2010, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.It was stated that the patient had a 20 mm limb to seal in the left common iliac artery (cia) on the date of implant, where a smaller aneurysm was visible that did not require treatment.On (b)(6) 2019, it was realized that the cia aneurysm had slowly grown.It was decided to treat the cia aneurysm with an extension of the previously implanted gore® excluder® trunk-ipsilateral leg endoprosthesis (rmt) on (b)(6) 2020 to treat prevent further growth of the cia aneurysm and to prevent a type ib endoleak of the previously implanted rmt.The patient tolerated the procedure.
Additional Manufacturer Narrative
Updated evaluation codes.Code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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: 9738063
• Report Number: 2017233-2020-00108
• Device Sequence Number: 18924218
• Product Code: MIH
• UDI-Device Identifier: 00733132610624
• UDI-Public: 00733132610624
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2020

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: 06/30/2011
• Device Model Number: RMT261412
• Device Catalogue Number: RMT261412
• Device Lot Number: 7987547
• 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: 02/21/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85