MAUDE Adverse Event Report: W.L. GORE AND ASSOCIATES VIABAHN ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT,ARTERIOVENOUS (AV) DIALYSIS ACCESS STENOSIS TREATMEN

Catalog Number VBJRO61502A

Device Problems Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964)

Patient Problem Stenosis (2263)

Event Date 09/06/2018

Event Type  malfunction  

Event Description

Pt had a fistulogram.Under ultrasound guidance, the cephalic vein was accessed.A 6-french microsheath was placed.The fistulogram and central venogram showed that there was no central venous stenosis, but there was an outflow stenosis of the cephalic vein.An upper extremity angiogram showed no inflow stenosis and anastomosis was widely patent.We gave heparin then upsized the sheath to a 6-french.A regalia wire was used to cross the stenosis.We then ballooned it with a 4 x 150 balloon.We then exchanged for a stiffer astato wire and then used a 6 x 150 viabahn endoprosthesis to cover the area of balloon angioplasty completion.This viabahn stent failed to deploy.He replaced it with another 6 x 150 viabahn stent which showed excellent results.The sheath was removed and a purse [invalid] suture was used for hemostasis.He tolerated the procedure well with good pulses.

• Brand Name: VIABAHN ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT,ARTERIOVENOUS (AV) DIALYSIS ACCESS STENOSIS TREATMEN
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES; humble TX 77345
• MDR Report Key: 7869220
• MDR Text Key: 120243567
• Report Number: MW5079748
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: VBJRO61502A
• Device Lot Number: VBJRO61502A
• 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: 52 YR
• Patient Weight: 113