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

Model Number CXT281412

Device Problem Difficult to Open or Close (2921)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® conformable aaa endoprosthesis with active control system.While trying to remove the constraining line, the physician noted that he was unable to do so.When he pulled back on the device, it began to constrain even more.He utilized a mob37 balloon to finish deploying the device, and it was able to fully deploy.The procedure was successfully completed, and the patient tolerated the procedure.The device will be returned for evaluation.

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.

Manufacturer Narrative

H6: code b01 - returned device was evaluated.The evaluation stated: ¿ the constraining loop end was inspected under magnification and was found to be undamaged and as expected.¿ it appears that the lock mandrel was placed in the lock mandrel hole of the leading tip as intended.¿ no noticeable damage existed on the any of the items returned for analysis.¿ the constraining mechanism was able to advance and retracted without issue, however due to the deployed state of the returned device, it could not be determined of the advancement / retraction of the constraining mechanism would have resulted in appropriate functionality of the constraining mechanism before it was removed from the catheter.Based on the findings from the evaluation, the physician¿s observation that ¿while trying to remove the constraining line, the physician noted that he was unable to do so.When he pulled back on the device, it began to constrain even more¿ could not be confirmed with the available information.Additionally, no manufacturing deficiency could be identified.H6: code c19 - evaluation of returned device was unable to reproduce reported issue.H6: code d15 - the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14775422
• MDR Text Key: 294508315
• Report Number: 3007284313-2022-01979
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: 00733132651054
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/19/2022

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 Model Number: CXT281412
• Device Catalogue Number: CXT281412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female