MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJR081502A

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Concomitant product(s): a 7fr sheath, 0.018" guidewire.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The delivery catheter was not returned; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2016, a gore® viabahn® endoprosthesis with heparin bioactive surface was being used for the treatment of an arteriovenous access site.The arteriovenous graft was from the cephalic artery to the axillary vein.It was stated that the axillary venous outflow was very tight and shut down so the stent graft was being placed in a collateral vessel next to the axillary vein.The collateral vessel was also very tight.An 8mm x 15cm device was advanced through a 7fr sheath over an.018" guidewire.The viabahn device was pulled out twice and the collateral vessel was ballooned both times.It still would not cross the lesion, so as the catheter was pulled back, the deployment line hung up on something and the device started to spontaneously deploy without pulling the deployment knob.The catheter was pulled back and the viabahn fully deployed away from the target site.It was reported to gore that as the catheter was removed it was observed that the distal tip was missing.It is unknown at this time where the distal tip is located.A bard fluency was used to cover the lesion.The physician stated that prior to the procedure, the scrub nurse was observed to be pulling and twisting on the distal tip.She was new to working with gore® viabahn® endoprosthesis with heparin bioactive surface but had worked previously with the gore® aortic devices.She was trying to pull a packaging mandrel out as on the gore® aortic devices, although a packaging mandrel is not used with gore® viabahn® endoprosthesis with heparin bioactive surface.

Manufacturer Narrative

Based on the event description and the subsequent investigation, we could not determine the cause of the event.However, we warn in the instructions for use that after removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

Event Description

On (b)(6) 2016, a gore® viabahn® endoprosthesis with heparin bioactive surface was being used for the treatment of an arteriovenous access site.The arteriovenous graft was from the cephalic vein to the axillary artery.It was stated that the cephalic venous outflow was very tight and shut down so the stent graft was being placed in a collateral vessel next to the cephalic vein.The collateral vessel was also very tight.An 8mm x 15cm device was advanced through a 7fr sheath over an.018" guidewire.The viabahn device was pulled out twice and the collateral vessel was ballooned both times.It still would not cross the lesion, so as the catheter was pulled back, the deployment line hung up on something and the device started to spontaneously deploy without pulling the deployment knob.The catheter was pulled back and the viabahn fully deployed away from the target site.It was reported to gore that as the catheter was removed it was observed that the distal tip was missing.It is unknown at this time where the distal tip is located.A bard fluency was used to cover the lesion.The physician stated that prior to the procedure, the scrub nurse was observed to be pulling and twisting on the distal tip.She was new to working with viabahn but had worked previously with the gore aortic devices.She was trying to pull a packaging mandrel out as on the aortic devices, although a packaging mandrel is not used with viabahn.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6230408
• MDR Text Key: 64522241
• Report Number: 2017233-2017-00011
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Catalogue Number: VBJR081502A
• Device Lot Number: 14615509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR