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

Model Number RLT231412

Device Problems Material Invagination (1336); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore: on (b)(6) 2021, the patient presented with an abdominal aortic aneurysm and underwent treatment utilizing three gore® excluder® aaa endoprostheses (one rlt device & two plc devices).The patient tolerated the procedure.On (b)(6) 2022, the patient presented with invagination of the previously placed rlt device in the infrarenal aorta and underwent treatment utilizing a gore® excluder® aaa endoprosthesis (pla).The pla device was implanted successfully and the invagination was resolved by coverage from the pla device.The patient tolerated the procedure.

Manufacturer Narrative

Added a1, a2.Added b3 / b4 / b5 / b6: describe event or problem.Added b7, g3/g4, h1/h2, and h6.Ifu statement: according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include but are not limited to endoprosthesis or delivery system: occlusion.

Event Description

Additional information was received about the reintervention event from medical records on january 11, 2024: on (b)(6) 2022, during the reintervention procedure, angiogram was done that showed the trunk ipsilateral graft had folded on itself in the infrarenal aorta and resulted in a near occlusion and there was severe stenosis in the left limb (gore® excluder® aaa endoprosthesis, contralateral leg, plc16l400).To resolve the infolding, a gore® excluder® aaa endoprosthesis (aortic extender -pla) was implanted proximal from the original trunk ipsilateral graft up to the renal arteries, then to improve the positioning of the device as it seemed to have crimped, the physician used a palmaz 5010 stent over a balloon to expand the kink in the aortic extender, however, in the process the aortic extender moved proximally (distance unknown) and covered the left renal artery.Physician then placed a self-expanding stent to take the contour across the renal artery alongside the gap as a snorkel into the aorta and the renal blood flow was improved then the physician placed two gore® viabahn® vbx balloon expandable endoprosthesis ((b)(6) into right iliac limb and (b)(6) into left iliac limb).While gaining access to the renal artery through various support catheters/sheaths and after ballooning of space between aortic wall and graft, physician was able to cannulate the left renal artery with wire but that caused a dissection, which was treated with a zilver 518 stent and ballooning.Completion runs show filling of the left and right kidneys, superior mesenteric artery (sma), and improvement in stenosis of the left common iliac limb.The total left renal ischemic time was of 2 hours.On (b)(6) 2022, patient presented to emergency department with shortness of breath for a week and elevated creatinine level.Renal artery duplex was done to rule out stenosis or obstruction which could be causing decline in renal function.Renal artery velocities were within normal limits.Patient was diagnosed with state 3 chronic kidney disease and discharged on (b)(6) 2022.1001-e:-unknown is used to capture the narrowing of the contralateral graft.1800-e:-implantable device events post deployment - other/unknown used to capture the device being crimped.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15080174
• MDR Text Key: 296373607
• Report Number: 3007284313-2022-02042
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: RLT231412
• Device Catalogue Number: RLT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female