MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PACR061002E

Device Problem Activation Failure (3270)

Patient Problems Aneurysm (1708); Insufficient Information (4580)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2/a3/a4: no patient details were provided.H3 other: the device investigation has not started yet.A product history review is being performed.Further details were requested from the physician, but were not provided yet.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

It was reported to gore that the patient underwent endovascular treatment for an unknown application with a gore® viabahn® endoprosthesis (vsx-device).It was stated that the vessel preparation was performed according ifu.The vsx-device was advanced to the lesion and positioned.During deployment of the last part of the device, the resistance of the deployment line increased and the last part did not deploy.Further information was requested, but was not provided yet.

Manufacturer Narrative

H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.H6 evaluation codes investigation findings c0706 and h6 evaluation codes investigation conclusions d1002 were chosen as the root cause of the observed exposure with kink in distal shaft as well as shifting and compression of endoprosthesis are consistent with device withdrawal during procedure.Engineering evaluation: the engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.Engineering evaluation of the device could not confirm the reported failure mode of failure to deploy, as deployment continued with traction at the knob during engineering evaluation.The root cause of the observed exposure with kink in distal shaft as well as shifting and compression of endoprosthesis are consistent with device withdrawal during procedure.

Event Description

It was reported to gore that the patient underwent endovascular treatment for an aneurysm in the popliteal artery with a gore® viabahn® endoprosthesis (vsx-device).It was stated that the vessel preparation was performed according ifu.The vsx-device was advanced to the lesion and positioned.During deployment of the last part of the device, the resistance of the deployment line increased and the last part did not deploy.The physician stopped pulling the deployment line and removed the vsx-device out of the body.As no other vsx-device was available, an open surgery had to be performed to solve the issue.The patient tolerated the procedure.

Manufacturer Narrative

B1 adverse event.B2 required intervention to prevent permanent impairment/damage (devices).H1/h2 type of reportable event: serious injury.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17238669
• MDR Text Key: 318403117
• Report Number: 2017233-2023-04076
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PACR061002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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 Outcome(s): Other; Required Intervention