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

Catalog Number BXA075901J

Device Problem Collapse (1099)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment using four gore® viabahn® vbx balloon expandable endoprosthesis (vbx) for total occlusion in the left common iliac artery.Two vbx were deployed from the left common iliac artery to the left external iliac artery.Two vbx (right: bxa075901j, left: bxa073901j) were deployed using the kissing stent technique.On an unknown date in (b)(6) 2020, the patient presented with claudication in the right leg.Computer tomography angiography revealed compression of the two vbx which were implanted using kissing stent technique.The thrombotic occlusion was observed in the right vbx.The left vbx was compressed but patent.On (b)(6) 2020, the patient underwent reintervention.Thrombectomy of right vbx was performed.The compressed areas were re-expanded using the kissing balloon technique.Two additional vbx were deployed using the kissing stent technique.On unknown date in (b)(6) 2021, the patient visited the facility because claudication reappeared.The compression of the vbx and thrombotic occlusion were confirmed.Surgical thrombectomy and re-dilation of the vbx were performed.On unknown date in (b)(6) 2021, at the follow-up, the compression of vbx was confirmed.Reportedly, the patient was asymptomatic.On (b)(6) 2021, the patient underwent reintervention.After the kissing balloon technique was performed, bare metal stents were placed on the proximal side of the vbx using the kissing stent technique.

Manufacturer Narrative

The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), states, ¿as with any balloon expandable stent, use of the gore® viabahn® vbx balloon expandable endoprosthesis in anatomy and procedures where the device is susceptible to severe external compression may result in permanent compression of the device.This can cause partial or complete device occlusion which may result in ischemia and related serious harms, potentially necessitating additional endovascular procedures or surgical intervention.¿.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13311124
• MDR Text Key: 286003663
• Report Number: 2017233-2022-02680
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Catalogue Number: BXA075901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male