MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number BXA115902A

Device Problems Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient sustained a motorcycle accident and was treated emergently for vessel damage to the innominate and right common carotid artery with four gore® viabahn® endoprostheses.On (b)(6) 2017 the patient exhibited an aneurysm just distal to the treated area.An additional procedure to extend the treatment was attempted with a gore® viabahn® vbx balloon expandable endoprosthesis.When the device was advanced to the target location balloon deployment was attempted, however the trailing end of the device seemed not to expand fully, taking on a tapered appearance, and jumped back into the aortic arch.The balloon was re-inflated in attempts to push the device back into place, but again the device jumped down into the aortic arch.A snare was advanced through axillary access in an attempt to drag the vbx device down to the common iliac region as a safe spot for the device to land without issue to the patient.The device landed vertically at the aortic bifurcation and was left there without any issue to the patient.The treatment was completed with coil embolization of the innominate artery and viabahn placement into the right common carotid artery.The patient did well following the procedure.

Manufacturer Narrative

Describe event or problem.Updated.Date received by mfr.Updated.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient sustained a motorcycle accident and was treated emergently for vessel damage to the innominate and right common carotid artery with four gore® viabahn® endoprostheses.On (b)(6) 2017 the patient exhibited an aneurysm just distal to the treated area.An additional procedure to extend the treatment was attempted with a gore® viabahn® vbx balloon expandable endoprosthesis.When the device was advanced to the target location balloon deployment was attempted, however the trailing end of the device seemed not to expand fully, taking on a tapered appearance, and jumped back into the aortic arch.The balloon was re-inflated in attempts to push the device back into place, but again the device jumped down into the aortic arch.A snare was advanced through axillary access in an attempt to remove the device from the patient, but this was not successful so an additional snare was advanced through a groin approach in an attempt to drag the vbx device down to the common iliac region as a safe spot for the device to land without issue to the patient.The device landed vertically at the aortic bifurcation and was left there without any issue to the patient.The treatment was completed with coil embolization of the innominate artery and viabahn placement into the right common carotid artery.The patient did well following the procedure.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7210944
• MDR Text Key: 98188849
• Report Number: 2017233-2018-00035
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Catalogue Number: BXA115902A
• Device Lot Number: 17531514
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR