MAUDE Adverse Event Report: WL GORE VIABAHN

Catalog Number BXA077902A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/07/2017

Event Type  malfunction  

Event Description

Surgeon deployed a viabahn vbx stent 7x79.As surgeon was pulling the stent delivery system out of vessel after deployment, the delivery system broke near the hub assembly portion of the catheter shaft.

• Brand Name: VIABAHN
• Type of Device: VIABAHN
• Manufacturer (Section D): WL GORE; 1505 north fourth st.; AZ 86004
• MDR Report Key: 7037451
• MDR Text Key: 92475463
• Report Number: MW5073354
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: (01)00733132637539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78