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

Model Number	BXA112902A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
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.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2020, the patient was undergoing a transcarotid cut down flow reversal procedure in the innominate artery using a gore® viabahn® vbx balloon expandable endoprosthesis.The device was advanced antegrade and deployed with no issue.After the successful deployment, the catheter was being withdrawn through the sheath.It was observed the balloon separated from the catheter.The balloon remained inside the portion of the sheath that was located inside of the patient.The balloon was withdrawn from the patient along with the sheath.The patient tolerated the procedure.
Additional Manufacturer Narrative
Evaluation of the returned device identified a catheter break located at 101 cm, as measured from the edge of shrink sleeve.The delivery catheter was necked and damaged in the final 10 cm prior to the point of catheter separation.The remaining portion of the delivery catheter and balloon component was inside a non-gore introducer sheath that was also returned.The endoprosthesis was not present having been successfully deployed within the patient.The root cause of the catheter separation during withdrawal of the vbx delivery catheter could not be determined.However, the ifu states ¿the delivery system is compatible with 0.035¿ (0.89 mm) guidewires.¿ the guidewire stuck within the delivery catheter was 0.026¿.

• 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
• MDR Report Key: 10977163
• Report Number: 2017233-2020-01515
• Device Sequence Number: 14034148
• Product Code: PRL
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 06/23/2022
• Device Model Number: BXA112902A
• Device Catalogue Number: BXA112902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1