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

Catalog Number VBCR081002A

Device Problem Activation Failure (3270)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2024, the patient underwent treatment for restenosis in an arterial graft (unknown manufacturer) segment using a gore® viabahn® endoprosthesis (viabahn device) in an unknown anatomical location.It was reported the physician was able to reach the target treatment zone by tracking the viabahn device over a terumo glidewire and through a merit medical 8 fr prelude introducer sheath.When it came time for the physician to pull on the deployment line, they were unable to pull the deployment line all the way.However, there was some device expansion at the distal end.The physician noticed under fluoroscopy that the sheath was not covering the viabahn device while it was partially expanding.The physician decided to withdraw the viabahn device through the introducer sheath and became stuck in the sheath.The physician then removed the sheath with the viabahn device inside along with the guidewire.The procedure was completed using another viabahn device with a new 8 fr sheath.There was no impact to the patient.

Manufacturer Narrative

H6: code b14 - a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6: code c21 - investigation is pending completion of product evaluation.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.

Manufacturer Narrative

H6: 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 confirms the reported failure mode of stuck deployment line.The root cause of the reported failure mode of stuck deployment line could not be established with the available information.The root cause of observed device damage during engineering evaluation is consistent with attempted withdrawal of partially expanded endoprosthesis into introducer sheath and other manipulation of device during procedure.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.H6: removed code d16 and added codes d15 and d1002 under investigation conclusions.D9: added date when device was returned to manufacture for an evaluation.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18673121
• MDR Text Key: 335444874
• Report Number: 2017233-2024-04615
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• 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: 05/10/2024

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: VBCR081002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2023
• 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