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

Model Number	BXA085902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
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.Patient weight was requested but not made available.Instructions for use for gore¿ viabahn¿ vbx balloon expandable endoprosthesis warnings section state, do not withdraw the gore¿ viabahn¿ vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore¿ viabahn¿ vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore¿ viabahn¿ vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore¿ viabahn¿ vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore¿ viabahn¿ vbx balloon expandable endoprosthesis or introducer sheath.
Event or Problem Description
The following was reported to gore: during treatment using a kissing technique in the common iliac arteries, the left side had tight stenosis and the right side had a previously implanted stent (unknown manufacturer).A 7fr cordis brite tip catheter introducer was used to advanced the gore¿ viabahn¿ vbx balloon expandable endoprosthesis (vbx device) over a.035 stiff wire guidewire.As reported, the vbx device did not reach the common iliac artery and as it was being pulled back through the sheath, the vbx device came off the balloon.The vbx device was deployed in the external iliac artery.A new vbx device was inserted and was able to reach the common iliac artery and deployed.The patient did not experience any adverse consequences.

• 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: 12387561
• Report Number: 2017233-2021-02318
• Device Sequence Number: 3476564
• Product Code: PRL
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 11/28/2023
• Device Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR