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

Catalog Number CXT281412

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.: code b22: results pending completion of investigation.H.6.: code c21: results pending completion of investigation.H.6.: d16: conclusion not yet available.H.3: evaluation findings: engineering inspected the leading tip and found that the lock pin was disengaged from the leading tip, which is consistent with the event description.There was no other damage observed on the leading tip or lock pin.Based on the findings from the evaluation, the lock pin was disengaged from the leading tip, which is consistent with the reported observation that a ¿a lock pin was disengaged from a distal tip.¿ the cause of the lock pin becoming disengaged could not be confirmed with the available information.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 information was reported to gore: on (b)(6), 2023, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.During the treatment, resistance was felt when inserting the device into a sheath.The device was removed and a lock pin was disengaged from a distal tip.The device was not used.Instead of the device, a gore® excluder® aaa endoprosthesis was used as a main device.The patient tolerated the procedure.Reportedly, the lock pin was disengaged during the preparation.During a implantation of gore® excluder® aaa endoprosthesis, after removed a clear knob a bleeding from a handle was observed.No treatment was performed for the bleeding.The patient tolerated the procedure.Regarding the lock pin disengagement the physician stated that since the device was wrapped in gauze, it could not be confirmed by direct observation.A staff who prepared the device was not always there, so the staff thought that the lock pin was usually disengagement from beginning and handed it over to the physician.Regarding the handle leakage the physician stated that there was more bleeding than usual.He would like to know the cause if it is identified.

Manufacturer Narrative

H.6.Investigation findings: code c21 updated to code c19.H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.Investigation conclusions: code d16 updated to code d15: cause not established.H.3.: device evaluation: performed by engineering showed the following: engineering inspected the leading tip and found that the lock pin was disengaged from the leading tip, which is consistent with the event description.There was no other damage observed on the leading tip or lock pin.Based on the findings from the evaluation, the lock pin was disengaged from the leading tip, which is consistent with the reported observation that a ¿a lock pin was disengaged from a distal tip.¿ the cause of the lock pin becoming disengaged could not be confirmed with the available information.No manufacturing deficiency could be identified.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17746435
• MDR Text Key: 323418010
• Report Number: 3007284313-2023-02757
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: 00733132651054
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXT281412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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