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

Model Number	PXT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: aspirin, allopurinol, ezetimibe, hydrochlorothiazide, metoprolol succinate, and triamcinolone.
Event or Problem Description
On (b)(6) 2010, 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 is unknown) revealed the gore® excluder® aaa endoprosthesis (pxt281416/7302070) had migrated distally (amount of migration is unknown).The cause of the migration appears to be disease progression, reportedly the aneurysm sac has enlarged proximally (amount of enlargement is unknown) of the renal arteries.The patient is not an endovascular candidate.The event is ongoing.
Additional Manufacturer Narrative
Revised investigation findings to code 213 ¿ no device problem found.A review of the manufacturing records indicated the lot met pre-release specifications.Revised investigation conclusion code to 50 ¿ adverse event related to patient condition.Imaging evaluation summary: two time-points available for evaluation: post-implantation cta dated (b)(6) 2020 and post-implantation cta dated (b)(6) 2021.On the (b)(6) 2020 time-point: the length from the right renal artery to the proximal circumferential device appears to be 3.6cm, by centerline.Aortic diameter just distal to the right renal artery appears to be 34.8mm.There appears to be lack of proximal device/wall apposition.On the (b)(6) 2021 time-point: the length from the right renal artery to the proximal circumferential device appears to be 3.7cm, by centerline.Aortic diameter just distal to the right renal artery appears to be 36.0mm.There appears to be lack of proximal device/wall apposition.Comparison axial images: max aaa diameter on (b)(6) 2020 appears to be 54.6mm x 50.9mm.Max aaa diameter on (b)(6) 2021 appears to be 56.4mm x 52.4mm.There appears to be a difference in maximum diameters between time-points.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to device migration and aneurysm enlargement.Additionally, according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), patient selection and treatment, additional considerations for patient selection include but are not limited to: patient¿s age, life expectancy, and co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery).

• 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: 11311328
• Report Number: 2953161-2021-01047
• Device Sequence Number: 3371689
• Product Code: MIH
• UDI-Device Identifier: 00733132610310
• UDI-Public: 00733132610310
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 10/31/2012
• Device Model Number: PXT281416
• Device Catalogue Number: PXT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR