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

Catalog Number	RMT311413
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 58 mm in diameter and was therefore treated with gore® excluder® aaa endoprostheses.On (b)(6) 2012, a follow-up ultrasound examination showed an aneurysm diameter of 52 mm.On (b)(6) 2013, follow-up computed tomography angiography (cta) imaging revealed an aneurysm diameter of 55 mm.On (b)(6) 2016, an aneurysm diameter of 82 mm was identified in the absence of a type 1 endoleak.The cause for the enlargement was reported to be thoraco-abdominal disease progression.On (b)(6) 2016, cta imaging revealed an aneurysm diameter of 57 mm.On (b)(6) 2017, the patient received a customized fenestrated endograft to treat the aneurysm enlargement.On (b)(6) 2017, another endovascular procedure was performed and a second customized fenestrated endoprosthesis was implanted.However, the patient was reported to have developed decreasing renal function post procedure.On an unknown date in 2017, the patient reportedly started permanent hemodialysis.On an unknown date in 2018, the patient expired.
Additional Manufacturer Narrative
Conclusions code 2: added code.Code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: aneurysm enlargement.
Additional Manufacturer Narrative
Describe event or problem: corrected previous initial device implant date (b)(6) 2012, to (b)(6) 2012.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 58 mm in diameter and was therefore treated with gore® excluder® aaa endoprostheses.

• 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: 8164538
• Report Number: 2017233-2018-00767
• Device Sequence Number: 11280206
• Product Code: MIH
• UDI-Device Identifier: 00733132610747
• UDI-Public: 00733132610747
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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: 12/31/2014
• Device Catalogue Number: RMT311413
• Device Lot Number: 9961523
• 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: 12/14/2018
• Supplement Report FDA Received Date: 03/05/2019; 03/05/2019
• 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: 82