MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Model Number VBH130502A

Device Problems Positioning Failure (1158); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 09/14/2017

Event Type  malfunction  

Event Description

The doctor attempted to deploy viabahn stent through a 12 fr check flo sheath.Despite this being the recommended sheath size for the device, the stent would not deploy.The doctor made attempts to withdraw the stent back through the sheath in order to remove it, but the stent would not withdraw.It came out in pieces in the sheath.The sheath had to be removed in order to remove the defective stent.Another viabahn was borrowed from the or (same size, same sheath) and was deployed without incident.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 6940268
• MDR Text Key: 89013791
• Report Number: 6940268
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: VBH130502A
• Device Catalogue Number: VBH130502A
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1