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

Model Number	BXA093901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
On (b)(6) 2020, the patient was being implanted with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) to treat stenosis of the brachiocephalic artery.An 8 fr silk road sheath was used during the procedure.It was reported the vbx was advanced and implanted with no issue.However, during withdrawal of the catheter resistance was met.The catheter was able to be withdrawn through the sheath.It was noted the balloon had become separated from the catheter and was located within the portion of the sheath in the patient.The sheath and balloon were successfully withdrawn from the patient together.The patient tolerated the procured.
Additional Manufacturer Narrative
Updated h6 investigation conclusion - 4315 cause not established.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11098137
• Report Number: 2017233-2020-01565
• Device Sequence Number: 13659042
• Product Code: PRL
• UDI-Device Identifier: 00733132637348
• UDI-Public: 00733132637348
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2022

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: 12/01/2022
• Device Model Number: BXA093901A
• Device Catalogue Number: BXA093901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/01/2021; 06/28/2022
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 04/01/2021; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown