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 Activation Failure (3270)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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.When removing a clear knob, a resistance was felt, and a proximal end of a stent graft seemed to be constrained.The physician decided that it would be dangerous to forcefully remove the clear knob, so a backup mechanism was used and removed a line 3.Attempt was made to remove the clear knob, however the proximal end of the stent graft seemed to be constrained again.A line 2 was removed using the backup mechanism.Attempt was made to remove the clear knob, however the proximal end of the stent graft seemed to be constrained again.When removing a line 4, the proximal end of the stent graft was constrained.The physician determined that the line 4 was lead this phenomenon, and if the line 4 was removed as it was, it would be difficult to predict the behavior of the device, so the line 4 was removed while holding the proximal side of the stent graft with a mob balloon.The treatment was completed successfully.The patient tolerated the procedure.

Manufacturer Narrative

The imaging evaluation performed by a clinical imaging specialist showed the following: short angiogram movie clips were provided for evaluation.The devices implanted reveal a tortuous aortic anatomy.Many of the movie clips show a device with the proximal portion of the trunk constrained and partially deployed, on and off, then finally the proximal device is fully deployed.On the video images at 17:25:22 contrast imaging shows lack of proximal circumferential device apposition, so the device is not fully deployed at this time.Many of the video clips showed the device moving up and down on the image due to pushing or pulling of the device.Angiogram images on the 17:32:44 video shows contrast on the images and there is flow through the implanted devices.There is no endoleak identified on the imaging provided for evaluation.On some of the later clips, after the contrast angiogram, a balloon catheter is seen being advanced in the patient to the level of the proximal trunk portion of the device.Ballooning is completed and the balloon catheter is moved proximally, past the proximal device markers.

• 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: kentaro okamoto ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18561337
• MDR Text Key: 333437504
• Report Number: 3007284313-2024-03013
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: CXT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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: 80 YR
• Patient Sex: Male