MAUDE Adverse Event Report: GORE VIABAHN; ENDOPROTHESIS WITH HEPARIN BIOAC

Catalog Number VBJ081002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Pt with malfunctioning left av fistula.Md placed stent, when deploying the stent, the distal end of the stent deployed within the sheath and was not able to come out.

• Brand Name: VIABAHN
• Type of Device: ENDOPROTHESIS WITH HEPARIN BIOAC
• Manufacturer (Section D): GORE; flagstaff AZ 86004
• MDR Report Key: 4755079
• MDR Text Key: 5887742
• Report Number: MW5042541
• Device Sequence Number: 1
• Product Code: NIP
• 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: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: VBJ081002
• Device Lot Number: 12017746
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 84