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	08/30/2021
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, a patient presented with common iliac stenosis and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.During the procedure, the physician advanced the vbx device past the end of an 8 fr sheath in an attempt to reposition the sheath.The physician then attempted to withdraw the vbx device back through the sheath, at which point the undeployed stent dislodged from the delivery catheter.A second vbx device was then successfully deployed over the dislodged stent, reportedly also covering the intended lesion.The patient tolerated the procedure.
Additional Manufacturer Narrative
Manufacturing records indicated the device met all pre-release specifications.The device itself was not accessible for testing.The following ifu statement is applicable to the event as reported: ¿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.¿.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12505625
• Report Number: 2017233-2021-02389
• Device Sequence Number: 14742319
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 09/08/2022
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• 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
• Patient Sex: Unknown