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

Model Number	BXA065901A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
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, two gore® viabahn® vbx balloon expandable endoprosthesis(s) (vbx device) were intended for use in the right and left common iliac.The left iliac was successfully treated with a vbx device.A vbx device was successfully deployed in the right iliac.However, an absolute pro vascular self-expanding stent was placed as an extension, due to a suspected dissection.Upon a final angiograph, it was noticed that the vessel had low flow.It was then confirmed that the devices were placed in a false lumen.The patient was brought to the operating room where a surgical conversion was completed with a fem-fem bypass.The patient did not experience any adverse consequences.The physician suspected that the dissection occurred during the advancement of the wire in the diseased vessel.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.H6 - component code, added code 515 (stent).H6 - investigations findings, updated code to 3221 (no finding available).H6 - investigations conclusions, updated code to 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: 12163485
• Report Number: 2017233-2021-02162
• Device Sequence Number: 11645201
• Product Code: PRL
• UDI-Device Identifier: 00733132637201
• UDI-Public: 00733132637201
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 12/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: BXA065901A
• Device Catalogue Number: BXA065901A
• 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: 07/01/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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: Hospitalization; Other
• Patient Age: 51 YR
• Patient Sex: Unknown