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

Model Number	BXAL085902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
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 or Problem 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
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12468089
• Report Number: 2017233-2021-02372
• Device Sequence Number: 11717907
• Product Code: PRL
• UDI-Device Identifier: 00733132637669
• UDI-Public: 00733132637669
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: BXAL085902A
• Device Catalogue Number: BXAL085902A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR