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
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 7933613
• Device Sequence Number: 857002
• Product Code: PFV
• UDI-Device Identifier: 00733132623952
• UDI-Public: (01)00733132623952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2018
• Report Date (Section F): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VBJR060502A
• Device Catalogue Number: VBJR060502A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 57
• Date Report Sent to FDA: 09/25/2018