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

Model Number	BXA112902A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
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
On (b)(6) 2020, a gore® viabahn® vbx balloon expandable endoprosthesis(vbx) was being placed as a innominate stent in conjunction with transcarotid artery re-vascularization (tcar) procedure.During the advancement of the device the physician had to use excessive force to get the device into place.After the device was successfully deployed, the physician was removing the device catheter through the 8fr tcar introducer sheath, and felt resistance.After the resistance was felt he continued to withdraw the catheter, and the catheter broke.The physician removed the remainder of the catheter and sheath in tandem.When it was removed, it was suspected that the balloon portion of the catheter hung up on the sheath tip.Patient did not suffer any adverse effects.
Additional Manufacturer Narrative
H6: component code 515 (stent) added.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.A product history review was conducted for the vbx device.The manufacturing records were reviewed, and the device lot met all pre-release specifications.Assessment of any potential failure modes and causes is not possible because the endo remains implanted and the delivery catheter was not returned.Cause for the reported insertion and withdrawal difficulty and the broken delivery catheter cannot be established.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• 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: 10775046
• Report Number: 2017233-2020-01404
• Device Sequence Number: 11028170
• Product Code: PRL
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 01/05/2022

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: 07/07/2022
• Device Model Number: BXA112902A
• Device Catalogue Number: BXA112902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/22/2021; 01/05/2022
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/22/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown