MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. STENT GORE VIABAHN 39MM 135CM 6MM 8MM 7FR 0.035IN-S20063384; ILIAC COVERED STENT, ARTERIAL

Model Number BXA063902A

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 08/27/2020

Event Type  Injury  

Event Description

Sattempt to remove the carotid filter.The retrieval system would not pass behind the vbx stent graft.We tried a variety of things such as low-profile balloon vertebral catheter quick cross catheter among others we could not get the device to pass behind the vbx stent graft.After consultation with others by the phone and in the operating room, we then opted to grab the filter with a snare.We were able to accomplish this in the internal carotid but we could not get the wire to move behind the vbx stent graft.At this point it was clear that the filter was retained and we are not going to be able to remove it.At this point contrast injection demonstrates no flow in the internal carotid.I believe with the snare and the snare sheath and the pulling on the vbx stent graft that we have invaginated the distal end of the stent and may have dissected the distal internal carotid artery.At this point we opted to open the carotid.Diagnosis for use: occlusion and stenosis of bilateral carotid arteries.Fda safety report id# (b)(4).

• Brand Name: STENT GORE VIABAHN 39MM 135CM 6MM 8MM 7FR 0.035IN-S20063384
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 10494002
• MDR Text Key: 205953378
• Report Number: MW5096436
• Device Sequence Number: 1
• Product Code: PRL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: BXA063902A
• Device Catalogue Number: BXA063902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82