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

Model Number VBJR060502A

Device Problems Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

Procedural notes: "the left femoral artery was cannulated.Guidewire was inserted.Over the guidewire, a 6-french sheath was advanced.At this time, a retrograde iliac arteriogram was performed visualizing the area of the blush leaking from the distal external iliac artery.At this time, a 6x5 viabahn covered stent was inserted over the wire.It did not deploy correctly.As such, the sheath was removed, a new 6-french sheath was advanced and a 6x5 viabahn stent was then inserted in the area of the leak, covering it.A repeat arteriogram revealed persistent leak.As such, a second stent covering a little further distally, just to and above the femoral head, was placed and then inflated and positioned.Repeat retrograde iliac arteriogram revealed no further leaking or bleeding.".

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st.; p.o. box 2400; flagstaff AZ 86004
• MDR Report Key: 7933613
• MDR Text Key: 122672005
• Report Number: 7933613
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623952
• UDI-Public: (01)00733132623952
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBJR060502A
• Device Catalogue Number: VBJR060502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 57