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

Model Number	RLT261416
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, aneurysm enlargement, endoprosthesis: migration.Images were provided to gore and an imaging evaluation was performed and showed the following: two time-points were available for evaluation: post-implantation computed tomograpy angiography (cta) images dated (b)(6) 2016 and post-implantation cta dated (b)(6) 2021.Cta images on (b)(6) 2016 appear to show: comparison cta series (arterial/delayed contrast) appear to show possible contrast outside the implanted device on the delayed series.The length from the right renal artery to the proximal circumferential device appears to be 14.7mm.The aortic diameter just distal to the right renal appears to be 22.3mm.The aortic diameter 14.7mm distal to the right renal appears to be 24.3mm.Cta images on (b)(6) 2021 appear to show: the length from the right renal to the proximal circumferential device appears to be 12.6mm.The aortic diameter just distal to the right renal appears to be 23.6mm.The aortic diameter 12.6mm distal to the right renal appears to be 26.5mm.There appears to be minimal apposition at the proximal end of the device.There appears to be contrast outside the implanted device within the proximal 10mm of circumferential device.Probable type 1a endoleak.The aortic diameter 14.5mm distal to the right renal appears to be 26.9mm.(aortic diameter at 14.7mm on (b)(6) 2016 appeared to be 24.3mm.) comparison cta series from both time points appear to show: there appears to be contrast outside the implanted device on the arterial and delayed series on (b)(6) 2021.Contrast appears to pool in the aneurysm sac.Maximum aneurysm diameters appear to be: delayed series images on (b)(6) 2016 ¿ 65.5mm x 74.1mm.Delayed series images on (b)(6) 2021 ¿ 80.5mm x 82.0mm.There appears to be aneurysm growth between time-points.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
I am forwarding information i received today for a case from (b)(6).Patient name: (b)(6).Dob: (b)(6).Endoleak: type 1a.Device: excluder.2 cta image sets (gore cloud): (b)(6) 2016 and (b)(6) 2021.
Additional Manufacturer Narrative
H6: secondary conclusion code added.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11666062
• Report Number: 3007284313-2021-01384
• Device Sequence Number: 3121811
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 06/11/2018
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 79 YR