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

Catalog Number	RLT231218
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: tylenol, albuterol, lipitor, tessalon, vitamin d, coreg, benadryl, prednisone, aspirin, prilosec, nitrostat, warfarin.The device remains implanted, so evaluation of the actual device was unable to be completed.Images were provided, and an imaging evaluation was performed.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.Images were provided, and the imaging evaluation stated the following: on the (b)(6) 2019 ct, there appears to be a proximal type i endoleak.One ct time point was received for review.Unable to confirm aneurysmal growth with the images received.On the (b)(6) 2019 angiogram, there appears to be aortic extenders implanted in the proximal end of the trunk-ipsilateral leg component that extend proximal to the renal arteries.On the final angiogram, there still appears to be an endoleak of indeterminate origin.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was noted that the patient's lowest accessory renal artery, located on the patient's left side, was preserved during the initial procedure.It was reported that follow-up ct identified a proximal type i endoleak on the trunk-ipsilateral leg component.No aneurysm enlargement was reported.On (b)(6) 2019 a revision was performed.Reportedly a 5cmx59mm gore® viabahn® vbx balloon expandable endoprosthesis was used to extend the patient's lowest accessory renal artery to preserve the patency of the artery (periscope technique).Three aortic extender components were used to treat the endoleak.Reportedly the endoleak was resolved.A leak was noted between the gore® viabahn® vbx balloon expandable endoprosthesis and an aortic extender component (gutter leak).The leak will reportedly be monitored.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
B.5.Additional event description added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection, and anatomical requirements for use of the trunk-ipsilateral leg endoprosthesis include, but are not limited to, minimal thrombus or calcification in the proximal aortic neck.
Event or Problem Description
It was reported that there was thrombus and plaque located in the patient's superior aortic neck that could have contributed to the proximal type i endoleak.

• 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: 9373153
• Report Number: 3007284313-2019-00360
• Device Sequence Number: 14025120
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/05/2019

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: 06/10/2021
• Device Catalogue Number: RLT231218
• Device Lot Number: 18232707
• 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: 11/25/2019
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73