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

Catalog Number RLT261412

Device Problems Insufficient Information (3190); Activation Failure (3270); Activation Problem (4042)

Patient Problems Calcium Deposits/Calcification (1758); Failure of Implant (1924)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted; however, the delivery catheter was provided for analysis.The investigation is in process.Further information will be provided.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) 2024, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.It was reported that at the 1st stage deployment of the excluder at the proximal neck, the live fluoroscopy showed that the device was not fully open (approx 80%, not fully opposed to vessel wall and oversized 26mm graft for 23 size vessel due to calcium).The graft moved distally after cannulation pigtail run as the patient aortic neck was angulated.It was reported that the device was reconstrained and re-positioned proximally.Attempt to reopen failed; black nut would not move completely to lt (about 80%).The physician said it was physically stopping to fully open.Removed constraining mechanism at this point and graft opened to about 90%.Finished deploying ipsilateral limb of the main body and then used reliant balloon to fully open trunk of main body.Reportedly, the device was fully expanded after releasing constraining mechanism and finishing distal limb.The physician then ballooned trunk of graft to achieve complete wall apposition.The physician believes that it was a faulty delivery system, aided by proof of black nut not being able to fully move to its lt position to fully open up graft after it was reconstrained.The procedure was completed as normal but added 26mm cuff at end.The physician is doing well.The field sales associate emailed some clarifications.Attempted to use back up system but 1st deployment string was no longer attached as it was deployed normally.Constraining mechanism was released normally, even with black nut not fully ¿open¿ position.The aortic neck angle was not recalled but it was within ifu.The delivery catheter was provided for analysis.

Manufacturer Narrative

H6: code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Code b20 was used for: the device remains implanted; however, the delivery catheter was provided for analysis.The delivery catheter was received by gore for analysis, and the device evaluation showed that the primary reported device failure mode, the inability for the endoprosthesis to fully expand as expected, could not be independently confirmed as the delivery catheter was returned without the endoprosthesis.The reported difficulty with the constraining mechanism could not be confirmed during evaluation of the returned device.The returned device was observed to be unremarkable during engineering evaluation: the black guide nut operated appropriately, the constraining loop eyelet presented without damage, and there was no damage to the olive nor lock pin.The cause could not be established for the reported device inability to fully expand nor the reported difficulty with the constraining mechanism.Code c22 was used to explain the following: the reported difficulty with the constraining mechanism and the device inability to fully expand could not be confirmed during evaluation of the returned device.Code d15 was used to explain the following: the root cause could not be established for the reported device inability to fully expand nor the reported difficulty with the constraining mechanism.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention or additional intraoperative procedure time include but are not limited to incomplete component deployment.B5: event description: the patient is doing well.

Event Description

The patient is doing well.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19102445
• MDR Text Key: 340453729
• Report Number: 3007284313-2024-03172
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020004
• 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: 05/13/2024

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: RLT261412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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: 82 YR
• Patient Sex: Female