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

Catalog Number BXA073902J

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/26/2021

Event Type  Injury  

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

The following information was reported to gore: on (b)(6) 2021, the patient underwent an endovascular treatment using a non-gore fenestrated stent graft (valiant) for an abdominal aortic aneurysm.Gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were to be implanted in the right renal artery.It was reported that there was stenosis at the ostium of the right renal artery.After a guidewire was cannulated into the right renal artery and the true lumen of the right renal artery was confirmed by angiography, the vbx device was inserted.While advancing the vbx device, the guidewire slipped out of the right renal artery into the sheath, therefore, the guidewire was again cannulated into the right renal artery.The vbx device was then implanted.After the implantation, the flow on the distal side of the vbx device in the right renal artery could not be confirmed by angiography.The cause of the occlusion was reported to be unknown.Considering the risk of rupture, no treatment for the occlusion was performed, and the patient was to be monitored with careful follow-up.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12468846
• MDR Text Key: 271318402
• Report Number: 2017233-2021-02375
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2023
• Device Catalogue Number: BXA073902J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR