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

Model Number VBCR101002A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

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: a gore® viabahn® endoprosthesis (vsx device) was intended for use in the subclavian artery for treatment of in-stent stenosis.After the vsx device was advanced through the previously implanted device, the physician-initiated deployment.After approximately half of the device had been deployed, the deployment line broke.The physician cut the deployment catheter to try and retrieve the deployment line, with no success.The physician started to manipulate the delivery catheter and introducer sheath and the remaining vsx device deployed.The patient did not experience any adverse consequences.

Manufacturer Narrative

Manufacturing records were reviewed, and the device met all pre-release specifications.The report of deployment difficulty (i.E., broken deployment line) could not be independently confirmed as no items were available to directly evaluate product performance.Therefore, the root cause of the reported deployment difficulty could not be established with the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15992510
• MDR Text Key: 305695565
• Report Number: 2017233-2022-03580
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132645824
• UDI-Public: 00733132645824
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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 Model Number: VBCR101002A
• Device Catalogue Number: VBCR101002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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