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

Catalog Number BXA083901J1

Device Problems Complete Blockage (1094); Collapse (1099)

Patient Problem Ischemia (1942)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

The following information was reported to gore: the following information was reported to gore: on (b)(6) 2020, the patient underwent intervention using two gore® viabahn® vbx balloon expandable endoprosthesis (vbx) for in-stent restenosis (misago) in the right iliac artery using a kissing stent technique.On (b)(6) 2020, the patient presented with pain in the right and left common iliac arteries.Computer tomography scan image revealed compression of the left vbx and thrombus.Since blood flow was not confirmed in the left vbx, the compression will be monitored.The thrombus in the proximal part of vbx will be treated using intraarterial injection urokinase.The doctor suggested that the device compression was caused by external pressure.See medwatch #2017233-2020-00416 for the right vbx device.

Manufacturer Narrative

Corrected data: d2.- common device name.Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot unk.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.The referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.The complaint was for a compressed device with no blood flow through stent.Crush resistance of the vbx device can be influenced by the stent ring material, stent ring geometry, stent ring spacing, and stent ring alignment.The stent rings are certified by the supplier for material and geometric properties.Stent rings are 100% verified during the manufacturing process to be free of visual deformities.Stent ring geometry, spacing, and alignment are 100% verified during the manufacturing process.The device history file was reviewed and no anomalies were identified.Based on the device examination 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: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10165828
• MDR Text Key: 195578500
• Report Number: 2017233-2020-00415
• Device Sequence Number: 1
• Product Code: PRL
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA083901J1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 52