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

Model Number	BXA117902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/11/2021
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 (vbx) device was intended for use in the left common iliac artery.After the vbx device was successfully delivered in the left common iliac through a 8fr x 90 terumo introducer sheath in right brachial artery.The vbx delivery catheter broke near the handle as it was being removed by the physician.The remaining delivery catheter was successfully removed from the patient.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6 - component code 515 (stent) added.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.H6 - investigation findings updated to code 3221 (no findings available).H6 - investigation conclusions updated to code 4315 (cause not established).

• 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: 12707790
• Report Number: 2017233-2021-02494
• Device Sequence Number: 13842621
• Product Code: PRL
• UDI-Device Identifier: 00733132637768
• UDI-Public: 00733132637768
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 08/05/2024
• Device Model Number: BXA117902A
• Device Catalogue Number: BXA117902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male