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

Catalog Number	RLT231216
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Images were sent to gore imaging and are being evaluated.
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.It was reported computed tomography images (dated (b)(6) 2018), revealed there is aneurysm sac enlargement, the amount is unknown.The cause of the enlargement is unknown.The event is ongoing.
Additional Manufacturer Narrative
Method code 3331 addition h6: code 22 addition images were sent to gore imaging services for evaluation.Per the evaluation three time-points are available for evaluation; post-implantation cta dated january 30, 2018, post-implantation cta dated may 18, 2018, and angiogram runs dated june 21, 2018.Images dated january 30, 2018, appear to illustrate contrast pooling in the central aneurysmal sac.A lumber artery near the proximal implanted device and a set of lumbar arteries more distal appear to have contrast in them at the level of the implanted device on the january 30, 2018 and may 18, 2018, time-points.Cannot confirm communication between the lumbar arteries and contrast pooling in the sac on either time point.Comparison axial images appear to show aneurysmal growth between the first two time-points; january 30, 2018, approximately ~70mm x 70mm and may 18, 2018, approximately ~80mm x 85mm.Unable to confirm contrast outside the implanted devices in the aneurysmal sac on the angiogram imaging of june 21, 2018.

• 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: 7700581
• Report Number: 2017233-2018-00382
• Device Sequence Number: 13678961
• Product Code: MIH
• UDI-Device Identifier: 00733132622344
• UDI-Public: 00733132622344
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 08/27/2018

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: 07/31/2017
• Device Catalogue Number: RLT231216
• Device Lot Number: 12984237
• 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: 07/18/2018
• Supplement Report FDA Received Date: 08/14/2018; 09/05/2018
• 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: Other
• Patient Age: 76 YR