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

Catalog Number BXA063902E

Device Problem Material Deformation (2976)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

As the device was discarded at the facility and no images were available, no investigation of the device and this case could be performed.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a stenosis in the common iliac artery with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that to treat a calcified stenosis of the common iliac artery, a vbx-device should be implanted.After insertion via a 7fr terumo sheath and advancement of the prosthesis, the angiogram showed that the stent was no longer in the correct position on the catheter.Reportedly, the vbx-device was removed, and the procedure finished successfully with a device from another manufacturer.There was no report of patient harm.The patient is doing fine.

Manufacturer Narrative

H6 evaluation codes component code was added as well as the investigation conclusion.Investigation conclusion: there was no device return associated with this complaint.A review of the manufacturing records indicated the device lot met all pre-release manufacturing specifications, including a final visual inspection and confirmation of acceptable stent profile using an image measurement system.Stent displacement was confirmed using the complaint description.The failure mode of stent displacement or dislodgement during insertion is captured within the gore® viabahn® vbx balloon expandable endoprosthesis risk files.The root cause of the stent displacement during advancement could not be established.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12171615
• MDR Text Key: 261653701
• Report Number: 2017233-2021-02171
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Catalogue Number: BXA063902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO GUIDE WIRE, 7FR TERUMO INTRODUCER SHEATH.; TERUMO GUIDE WIRE, 7FR TERUMO INTRODUCER SHEATH.
• Patient Age: 74 YR
• Patient Sex: Female