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

Catalog Number BXA117902B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/07/2020

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2020 a patient underwent treatment of an internal iliac aneurysm with a gore® excluder® iliac branch endoprosthesis.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized for the internal iliac artery component.The gore® viabahn® vbx balloon expandable endoprosthesis was advanced over an amplatz wire through an 8fr 90cm destination sheath in the axillary artery.The device was tight in this sheath however it tracked into position and deployed successfully.As the balloon catheter was being removed it was tight in the sheath and the hub portion broke away from the delivery catheter.The wire and delivery catheter were then removed together successfully.The patient outcome was good.

Manufacturer Narrative

Section c1: name: cbas® heparin surface, manufacturer/compounder: w.L.Gore & associates, inc., lot number: 21848925, additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H.6.Results code 2: 213: the engineering evaluation stated the following: the device was identified to be an 11 x 79 x 1350 mm configuration, which matches the event description.The gore® viabahn® vbx balloon expandable endoprosthesis was sent back deployed.The catheter hub was sent back separated from the rest of the delivery system.Catheter material was present in the catheter hub indicating a catheter tensile failure rather than a bond failure.Catheter damage was observed at 0 - 0.5 cm, 5.5 ¿ 8.5 cm, and 14.5, 15 cm from the point of separation.The device history file was reviewed and no anomalies were identified.Samples of 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 visual damage.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

H.1.Updated.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• 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: 10085255
• MDR Text Key: 195589125
• Report Number: 2017233-2020-00387
• 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,Followup,Followup
• Report Date: 08/05/2020

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: 01/04/2023
• Device Catalogue Number: BXA117902B
• Device Lot Number: 21848925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/03/2020; 08/05/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR