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

Catalog Number BXA105902E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Event Description

The patient presented with a diseased lesion within the common iliac artery where it was intended to implant the gore® viabahn® vbx balloon expandable endoprosthesis as a bridging stent into the internal iliac artery.After the endoprosthesis was successfully deployed within the target lesion, it was reported that the balloon detached from the device catheter while the device was removed through the sheath.It was stated that some friction was experienced while device removal.As the balloon detached inside the introducer sheath, it was stated that the balloon could have been removed without any difficulties.

Manufacturer Narrative

A - patient information: it was requested but not disclosed.H6-code 10: the device remains implanted in the patient.The delivery system was returned for investigation.H6-code 213: a review of the manufacturing records indicated the device met pre-release specifications.The gore® viabahn® vbx balloon expandable delivery system was returned with the hub detached and the catheter stuck within a non-gore introducer sheath.The catheter displayed necking in the first 2 cm as well as 5-6 cm from the proximal end of the delivery system.The device history file was reviewed and no anomalies were identified.The delivery catheter lot met specifications for tensile strength.The catheter of the vbx delivery system is 100% inspected at the end of the manufacturing process for any mechanical damage, including necking.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 9498301
• MDR Text Key: 194020614
• Report Number: 2017233-2019-01259
• 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: 01/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: BXA105902E
• Device Lot Number: 21091340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1