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

Model Number	BXA082902A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
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.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020, the patient underwent treatment for stenosis in the femoral artery.The kissing stent technique using gore® viabahn® vbx balloon expandable endoprostheses was used for the procedure.A 7fr destination sheath was used during the procedure.The gore® viabahn® vbx balloon expandable endoprosthesis met resistance advancing and was not able to advance through the patient¿s calcified iliac.The device then was attempted to be withdrawn through the sheath.The stent detached from the catheter in the patient¿s femoral artery.A snared graft was used to retrieve the device.Two additional gore® viabahn® vbx balloon expandable endoprostheses were used to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
The product evaluation states: the complaint first indicates an inability to advance the catheter through calcified anatomy before the endoprosthesis became dislodged from the catheter during withdrawal through a sheath.Dislodgement of the endo from the catheter is confirmed based on the complaint description which provides additional information about subsequent withdrawal actions during the procedure.Considering warnings in the ifu against withdrawing the delivery system with stent still mounted, it is probable that cause of the dislodged endoprosthesis is related to use outside the device ifu.

• 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: 11343153
• Report Number: 2017233-2021-01682
• Device Sequence Number: 4831743
• Product Code: PRL
• UDI-Device Identifier: 00733132637553
• UDI-Public: 00733132637553
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2021

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: 03/23/2023
• Device Model Number: BXA082902A
• Device Catalogue Number: BXA082902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 04/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/29/2021; 07/01/2021
• Patient Sequence Number: 1