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

Catalog Number	RLT261412
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The following was reported to gore: on (b)(6) 2024, an abdominal aortic aneurysm was being treated with a gore® excluder® aaa endoprosthesis.During deployment, the graft did not fully deploy.A balloon was advanced.While advancing, the device continued to slowly expand, but did not reach full diameter.Then the device was successfully ballooned to full diameter.After ballooning, the physician attempted to remove the constraining mechanism.However, the clear handle would not disengage.Each time the handle was pulled back, the proximal end of the right side of the graft would be pulled down.Another balloon was advanced into the graft.When the balloon was inflated, the handle was pulled again.Although there was resistance, the delivery system was able to be removed with no migration of the device.The patient had no adverse events related to either device event.It was reported that the final placement of the device was excellent.Code 1900-e was used for the difficulty removing the constraining mechanism.
Additional Manufacturer Narrative
H.6.Type of investigation code b01: the device evaluation showed the following: visual examination of the device, including of the lock pin, leading olive, constraining loop, and handle screw assembly did not reveal any abnormalities.Engineering was able to advance the guide nut along the length of the screw assembly with no observed resistance.Engineering was able to pull back the lock button without any observed resistance.The anchor staking pocket was properly and sufficiently filled with glue.Without intra-operative imaging, the observation that the ¿graft did not fully deploy¿ could not be confirmed.Based on the findings from this evaluation, the observation of ¿difficulty removing the constraining mechanism¿ was not confirmed.The likely cause for the reported difficulty removing the constraining mechanism for the gore® excluder® aaa endoprosthesis could not be determined with the available information.H.6.Type of investigation code b14: a review of the manufacturing records for this device verified the lot met all pre-release specifications.H.6.Investigation conclusions code d15: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.Updated h.6.Investigation conclusions from d16 to d15.Updated h.6.Investigation findings codes from c21 to c07 and c19.Added h.6.Type of investigation codes b01, b13, b14.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19495846
• Report Number: 3007284313-2024-03300
• Device Sequence Number: 20968885
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2026
• Device Catalogue Number: RLT261412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG