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	09/14/2018
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
The following was reported to gore: on (b)(6) 2010, the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprostheses in an angulated neck (>60°).On (b)(6) 2018, a proximal type i endoleak was identified and unsuccessfully treated with endovascular refixation on (b)(6) 2018.It was stated that the postop ct showed a persistent endoleak.The patient denied the offered surgical treatment.
Additional Manufacturer Narrative
Post-implantation ct images dated on (b)(6) 2018 and post-implantation ct images dated on (b)(6) 2018 were provided to gore for evaluation.The evaluation showed the following: on (b)(6) 2018: there appears to be contrast outside of the proximal end of the device (type i endoleak).On (b)(6) 2018: there appears to be contrast outside of the proximal end of the device.The contrast is more visible on the delayed ct.Endoleak of indeterminate origin.There appears to be an unknown density in the aneurysmal sac.This is visible on both time-points.There appear to be patent lumbar arteries.The maximum aneurysmal diameter appears to be 82mm x 82.6mm and 82.2mm x 83.4mm.

• 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: 8273439
• Report Number: 2017233-2019-00046
• Device Sequence Number: 138127
• Product Code: MIH
• UDI-Device Identifier: 00733132610747
• UDI-Public: 00733132610747
• 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): 02/11/2019

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: 06/30/2011
• Device Catalogue Number: RMT311413
• Device Lot Number: 7866725
• 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: 01/24/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 84