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

Catalog Number CXT281412E

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023 a patient was treated for abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis with active control system.Reportedly, during the procedure, the deployment handle failed.The physician opened the hatch on the handle to reach the backup deployment mechanism and noted that the deployment line was disconnected.The physician used a surgical clamp to manually deploy the device.The patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.The patient id was not provided.A manufacturer placeholder has been given here instead.Device evaluated by mfr: the device has been returned and an evaluation is now in progress.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.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.The device evaluation performed by engineering showed the following: · as returned, the constraining loop was not attached to the constraining mechanism and the constraining loop was still contained with the catheter of the device.· the constraining loop had been partially pulled distally as it was not present at the proximal end of the catheter and approximately 57 cm of the constraining loop was exiting the distal end from the back of the spine cover.· there was an indent within the glue on the guide nut, indicating the constraining loop was once present within the guide nut.There was no damage to the distal end of the constraining loop.· engineering observed constraining loop shrink tube bunching within the access hatch and manifold which prevented the full removal of the constraining loop wire from the catheter.· engineering determined that the constraining loop appeared to have the expected routing pattern within the manifold and exited the appropriate manifold lower gate.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

Event Description

It was reported that on (b)(6) 2023 a patient was treated for abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis.Reportedly, during the procedure, the deployment handle failed.The physician opened the hatch on the handle to reach the backup deployment mechanism and noted that the deployment line was disconnected.The physician used a surgical clamp to manually deploy the device.The patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16596416
• MDR Text Key: 312319105
• Report Number: 2017233-2023-03810
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200030
• 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,Followup
• Report Date: 08/31/2023

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 Catalogue Number: CXT281412E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 08/31/2023
• Supplement Dates FDA Received: 08/24/2023; 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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