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

Model Number	PXT231416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: vibramycin, bumex, lipitor, aldactone, protonix, coreg, levothyroxine, potassium supplements, and multi vitamin.
Event or Problem Description
On (b)(6) 2009, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a proximal type i endoleak (date and modality of images is unknown).There is aneurysm sac enlargement reported (amount is unknown).The cause for the type i endoleak is unknown.On (b)(6) 2020, the physician reintervened and implanted a palmaz stent (50x10) and ballooned.The endoleak was resolved.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Addition post implant computed tomography images dated (b)(6) 2020 were sent to gore imaging services for evaluation.Per the evaluation, there is one time-point available for evaluation and there appears to be dual right renal arteries.The distal right renal appears to be lowest by centerline.Aortic diameter just distal to the distal right renal appears to be 24.6mm.Aortic diameter -8mm distal to the distal right renal appears to be 26.0mm.Aortic diameter 15mm distal to the distal right renal appears to be 27.2mm.Contrast can be visualized outside the implanted device within the proximal 15mm from the distal right renal artery which is highly suggestive of a type 1a endoleak.There appears to be a lighter density around the device.This is not contrast outside the implanted device because it is visualized on all image series including the non-contrast series.Maximum diameter of the aneurysm appears to be 58.8mm x 83.6mm on (b)(6) 2020.Cannot confirm aneurysm growth or disease progression with one time-point.Addition h6: code 213: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 22: 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 endoleak.

• 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: 11219795
• Report Number: 2953161-2021-01042
• Device Sequence Number: 19815334
• Product Code: MIH
• UDI-Device Identifier: 00733132610150
• UDI-Public: 00733132610150
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 03/31/2012
• Device Model Number: PXT231416
• Device Catalogue Number: PXT231416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 73