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

Model Number	RLT311415
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Renal Failure (2041); Obstruction/Occlusion (2422)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, this patient was treated with gore® excluder® aaa endoprostheses as well as gore® excluder® iliac branch endoprostheses for an abdominal aneurysm and an iliac artery aneurysm on the right side.On (b)(6) 2019, as currently the date of best estimate, the patient underwent follow-up computed tomography (ct) imaging as he was feeling unwell.The scan revealed that the implanted gore® excluder® trunk-ipsilateral leg component rlt311415 had migrated proximal for a length of less than 10 mm, partially covering the renal arteries.The patient suffered temporary impaired renal function that subsequently resolved.A reintervention was reportedly not performed.
Event or Problem Description
On (b)(6) 2019, the patient underwent follow-up computed tomography (ct) imaging as he was feeling unwell.
Additional Manufacturer Narrative
Report task section: manufacture plant: updated information.Manufacturer id: updated to correct manufacturer registration number 3007284313.H6, code 213: the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H6, code 22: 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 component migration, renal complication (e.G.Occlusion, insufficiency).Additionally, the ifu recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10 ¿ 21% oversizing).It is recommended an aortic endoprosthesis diameter of 35 mm treat an aortic vessel diameter of 30 to 32 mm.
Additional Manufacturer Narrative
H6.Conclusions code 1: corrected code.The following statement in the previous medwatch report sent august 29, 2021, is withdrawn : "additionally, the ifu recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10 ¿ 21% oversizing).It is recommended an aortic endoprosthesis diameter of 35 mm treat an aortic vessel diameter of 30 to 32 mm." as only post-implantation computed tomography angiography (cta) images were available, the claim of device sizing being outside of the instructions for use in this event cannot be establilshed.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10284148
• Report Number: 2017233-2020-00467
• Device Sequence Number: 2576927
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 05/14/2022
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Device Lot Number: 20599219
• 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; Not provided
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/29/2020; 02/17/2021
• 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; Other