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

Model Number	BXA075902A
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
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 subtotal highly calcified stenosis in the right common iliac artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.It was reported that the physician advanced the vbx device across the stenotic lesion, then pulled the vbx device back in place at the iliac bifurcation.The physician reported that the fit in the common iliac artery felt very tight, and after pulling the device back in place to take an image before initiating deployment, it was noticed that the vbx device had dislodged from the balloon delivery catheter.The dislodged stent was partially covering the internal iliac artery, so the physician used the sheath and delivery system to push the vbx stent back up into the common iliac artery.The physician was then able to advance the balloon delivery catheter back up inside the vbx device and completed deployment.This method shortened the length of the vbx device, so another 7mm x 59mm vbx was placed proximal to the initial vbx device in order to completely cover the lesion.The patient tolerated the procedure and the stenosis was successfully covered.

• 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
• 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: 12916004
• Report Number: 2017233-2021-02577
• Device Sequence Number: 5644917
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 08/04/2024
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown