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

Catalog Number	RLT351416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to surgical conversion.
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 that computed tomography (ct) images (date unknown) revealed the proximal portion of the implanted gore® excluder® aaa endoprosthesis had migrated into the aortic aneurysm sac (exact amount of migration is unknown).Reportedly, the images revealed that approximately three of the anchors were still in the abdominal aorta but the graft had separated from the anchors and the graft had slipped into the aneurysm sac.The trunk of the device was found at the bottom of the aneurysm sac, both limbs of the device were patent, and the anchors of the stent were found in the intramural thrombus.On (b)(6) 2019, the physician performed a partial explant of the gore® excluder® aaa endoprosthesis (rlt351416) and left the bifurcation of the endoprosthesis and the limbs and sew a dacron graft to the existing excluder® device and the proximal aortic neck.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Addition: images were sent to gore imaging services for evaluation.Images provided are post-implant cta dated (b)(6), 2014, post-implant cta/pre-explant cta, cone beam ct and cone beam ct post explant, all dated (b)(6), 2019.Per the evaluation, images dated (b)(6), 2014, revealed the diameter just distal to the left renal appears to measure ~ 27 mm.Diameter ~ 8.5 mm distal to the left renal appears to measure ~ 32 mm.Diameter ~ 15 mm distal to the left renal appears to measure ~ 33 mm.Length from the left renal to the flow divider appears to measure ~ 56 mm.Length from the left renal to the left internal iliac artery (liia) appears to measure ~ 191 mm.Length from the left renal to the right internal iliac artery (riia) appears to measure ~ 228 mm.There appears to be a metallic density present at the level of the left renal artery.Images dated (b)(6), 2019 revealed the length from the left renal artery to the proximal end of the device appears to measure ~ 53 mm on centerline reconstruction.Length from the left renal to the flow divider appear to measure ~ 98 mm.Length from the left renal to the liia appears to measure ~ 231 mm.Length from the left renal to the riia appears to measure ~ 260 mm.There appears to be a metallic density present at the level of the left renal artery.There appears to be a metallic density present ~ 12 mm distal to the left renal artery.There appears to be multiple separations of the graft on the post-explant image.Multiple attempts were made to obtain additional information for this event.As no additional information has been received, this event will be closed with the provided information.

• 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: 8445365
• Report Number: 2017233-2019-00168
• Device Sequence Number: 2887919
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/16/2019

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: 03/31/2017
• Device Catalogue Number: RLT351416
• Device Lot Number: 12564220
• 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: 03/22/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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: 65 YR
• Patient Weight: 76