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

Model Number RLT231412

Device Problem Difficult to Open or Close (2921)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The device was deployed too high, covering the renal, so the physician reconstrained the device and moved it down without issue.Angio showed that the device was still covering the renal, so the physician attempted to reconstrain and move it further down.He was unable to get the device to constrain, so he opened the hatch and attempted to constrain it that way.It was unsuccessful, so he then tried to move it down by pulling down on the delivery catheter, but the device would not move, and the constraining mechanism broke on the second attempt.He could not get into the gate and was unable to move the trunk any, so he proceeded to convert to an open repair.The gate was wedged into the aneurysm shelf so there was not a good endo solution.

Manufacturer Narrative

H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 4315.H.6.Type of investigation code 4118 updated to code 10 with completion of device evaluation.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12823459
• MDR Text Key: 282564845
• Report Number: 3007284313-2021-01661
• 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
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: RLT231412
• Device Catalogue Number: RLT231412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male