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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: acyclovir, amlodipine, aspirin, atorvastatin, benazepril, diphenhydramine, neurontin, nitroglycerin, and xarelto.Images were sent to gore imaging services for evaluation.Per the evaluation one time-point was available for evaluation, post-implantation ct dated (b)(6) 2019.3d images appear to show the device to be deployed with the limbs front to back instead of side by side.Aortic diameter just distal to the left renal artery appears to be 20mm.Aortic diameter ~8mm distal to the left renal appears to be 22.5mm.Aortic diameter ~8mm distal to the left renal, inside the device, appears to be 15.3mm.Aortic diameter 15mm distal to the left renal appears to be 27.1mm.Aortic diameter 15mm distal to the left renal, inside the device, appears to be 19.1mm.The proximal device appears to be bunched up at the 1st aortic angle.Proximal aortic angle distal to the left renal appears to be 26 degrees.The second aortic angulation appears to be 53 degrees.This angulation appears to be located at the level of the device flow divider.Diameter in the contralateral limb, that extends into the rci, at this level appears to be ~11.4mm.The ipsilateral limb at the level just distal to the flow divider appears to be compressed due to aortic angulation and the position of the deployed device.Diameter within the ipsilateral limb, at this level, appears to be ~6.1mm.Diameters of the proximal ~25mm of the ipsilateral limb, that extends into the lci, appear to range from ~3.5mm ¿ 6.4mm.
Event or Problem Description
On (b)(6) 2018, this patient underwent an endovascular repair for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the patient presented to the hospital with lower limb claudication.Computed tomography (ct) dated (b)(6) 2019, revealed the rlt351416/18460773 device was compressed below the flow divider on the ipsilateral limb.The limb was patent.On (b)(6) 2019, the physician reintervened and implanted a gore® viabahn® device in the collapsed area.The area was opened and the patient tolerated the procedure.

• 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: 8571701
• Report Number: 3007284313-2019-00127
• Device Sequence Number: 13912376
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 08/10/2021
• Device Catalogue Number: RLT351416
• Device Lot Number: 18460773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2019
• 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: 78 YR
• Patient Weight: 85