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

Model Number	BXA085902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in 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 gore® viabahn® vbx balloon expandable endoprosthesis was intended for use in the iliac artery to treat severe occlusion.The physician made a few attempts to cross the lesion but could not cross the severe occlusion.The decision was made to remove the device and perform an angioplasty.During the removal of the device it had become dislodged.The physician attempted to remove the device with a snare, but was unsuccessful.The physician then advanced a balloon through the device and deployed the vbx device in the vessel.
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12302325
• Report Number: 2017233-2021-02230
• Device Sequence Number: 14335782
• Product Code: PRL
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown