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

Model Number	BXA083901A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	10/18/2021
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, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device was intended for use in the iliac artery.During the advancement of the vbx device, the physician was met with resistance in the calcified lesion.When the physician attempted to remove the vbx device, it had become dislodged in the calcification.The decision was made treat the patient with open procedure.The physician didn't feel this was a good place leave the vbx device and removed it with a snare.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Review of device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation was completed with the following information.It was reported that a gore® viabahn® vbx balloon expandable endoprosthesis device met resistance, was unable to reach target location and the endoprosthesis became dislodged.The vbx device was returned with the endoprosthesis separated from the delivery system.The stent rings of the endoprosthesis were compressed longitudinally, overlapping, and nesting together.Bent and delaminated rings were also observed.The cause of failure to advance, and the associated stent dislodgement, could not be confirmed by the device evaluation.However, the complaint description states, when the physician attempted to remove the vbx device, it had become dislodged in the calcification.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements in the directions for use, treatment of vessel section: percutaneous transluminal angioplasty (pta).It is recommended to pre-dilate the lesion to allow for easy passage of the gore®viabahn® vbx balloon expandable endoprosthesis.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: 12748748
• Report Number: 2017233-2021-02511
• Device Sequence Number: 17321880
• Product Code: PRL
• UDI-Device Identifier: 00733132637300
• UDI-Public: 00733132637300
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2024
• Device Model Number: BXA083901A
• Device Catalogue Number: BXA083901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown