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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Evaluation of returned device pending.
Event or Problem Description
It was reported to gore that the gore® viabahn® vbx balloon expandable endoprosthesis came detached from the balloon within the patient.Reportedly the device was able to be snared by the physician and removed.The procedure was completed using another vbx device.
Additional Manufacturer Narrative
H6: clinical code changed to 4582.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H1: reportable event changed to malfunction (initial report correctly identified this event as a malfunction; follow-up report incorrectly stated serious injury).H6: component code corrected to 515 (stent).
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device lots met all pre-release.Manufacturing.Specifications.The returned device was confirmed as the delivery system (135 cm) for a gore® viabahn® vbx balloon expandable endoprosthesis (7 x 59 mm) device.The endoprosthesis was not present on the balloon and was not returned with the delivery system.The cause of the reported failure mode of endoprosthesis loses retention to delivery system could not be established with the information provided, including the device evaluation.It was reported that the physician suspected the stent dislodged due to calcification in the common iliac artery.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13635212
• Report Number: 2017233-2022-02775
• Device Sequence Number: 13984448
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: BXA075902A
• Device Catalogue Number: BXA075902A
• Device Lot Number: 23476776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022; 02/03/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/25/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Unknown