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

Catalog Number RLT261216J

Device Problem Activation Failure (3270)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.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

On (b)(6) 2023, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During deployment of the trunk-ipsilateral leg component, the trunk part and the contralateral leg hole were not opened almost at all.The physician checked the access hatch and found no problem.Then he constrained the proximal trunk and twisted the delivery catheter a little, resulting only slight expansion of the contralateral leg hole.Moreover, the proximal end of the trunk was not reopened even after the physician turned the constraining dial.Thus, the physician deployed the ipsilateral leg while fixing the delivery catheter by forceps, before the contra gate cannulation.After the ipsilateral deployment, the trunk and the contralateral leg hole were slowly being opened.Balloon touch-up was performed with a gore® molding & occlusion balloon catheter and the deployment of the trunk-ipsilateral leg was completed.Thereafter, all the planned devices were deployed without further problems.The patient tolerated the procedure.No injury to the patient was reported.The reporting physician commented as follows: the patient had tortuous aorta and the trunk-ipsilateral leg could not be opened possibly due to a narrowing part of the aorta.Or, something in the device structure might have affected it.The cause of the event was unknown.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Product evaluation summary: the reported failure mode of failure to fully expand could not be independently confirmed.No clinical images, nor the physical device were available to allow for evaluation of the reported failure modes.Based on the reported information and attached case report the aortic neck tapered from 23mm to 19mm, but the intended diameter for a 26mm device is 22-23mm.Additionally, the aorta appears angulated, and it was reported to be tortuous.However, it is unknown if the size and tortuosity of the aorta contributed to the failure to fully expand.Therefore, the root cause of the trunk-ipsilateral leg failure to fully expand cannot be established with the available information.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18353231
• MDR Text Key: 330819859
• Report Number: 3007284313-2023-02956
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RLT261216J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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
• Patient Age: 89 YR
• Patient Sex: Female