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

Model Number	BXA083902A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, the patient presented with calcification in the common iliac and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician was attempting to advance the vbx over a bifurcation but met resistance.The physician then attempted to remove the device and as it was being pulled back through the sheath, the undeployed stent fell off the shaft.The physician was able to successfully recapture and remove the stent with a snare.The device was discarded.The procedure was completed using another vbx device.The patient tolerated the procedure.The physician suspected that pulling the device back into the sheath is what caused the issue.Patient information was requested but is not available.

• 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: 12083962
• Report Number: 2017233-2021-02120
• Device Sequence Number: 3235657
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 09/06/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1