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

Model Number BXAL085902A

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

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 was reported to gore: on (b)(6) 2021 a patient presented with an iliac artery aneurysm and underwent treatment which included use of a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.The surgeon intended to use the vbx device in conjunction with a gore® excluder® iliac branch endoprosthesis (ibe) device in the right internal/external iliac artery gate.While attempting to position the device, the vbx device dislodged from the balloon inside of the patient.The device could not be moved, so it was left undeployed where it dislodged.It was reported that the device may have caught on the edge of the ibe device or on the front edge of the sheath while pulling back in an attempt to place the device, causing dislodgement.The procedure was completed without further issue by coiling the internal iliac artery and placing devices over the vbx device.The patient tolerated the procedure.It was also reported that the 12fr gore® dryseal flex introducer sheath had not been completely extended into the internal iliac artery to provide protection for the vbx device.

• 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: 12468089
• MDR Text Key: 271303154
• Report Number: 2017233-2021-02372
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637669
• UDI-Public: 00733132637669
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: BXAL085902A
• Device Catalogue Number: BXAL085902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR