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

Model Number	BXA097901A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was to be delivered for treatment of stenosis in the left common iliac.However, when the physician was advancing the device over the aortic bifurcation he felt resistance and removed the device.The physician wanted to pre-balloon the calcification before further advancing the device.When the catheter was removed it was noticed that the device had become dislodged in the calcification.The physician advanced a 2mm x 100mm (manufacturer unknown) through the device and expanded it enough to advance a 4mm x 100mm (manufacturer unknown) balloon through the device and expanded the device enough to get the original vbx catheter through the device and successfully deployed the device to complete the procedure.The patient tolerated the procedure and is doing well.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.Crush force is controlled through machine maintenance and calibration.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.D2, common device name - iliac covered stent, arterial.

• 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: 10478527
• Report Number: 2017233-2020-01196
• Device Sequence Number: 16788771
• Product Code: PRL
• UDI-Device Identifier: 00733132637591
• UDI-Public: 00733132637591
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: No Information
• Device Expiration Date: 10/19/2022
• Device Model Number: BXA097901A
• Device Catalogue Number: BXA097901A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1