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

Model Number	BXA072902A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, the patient was being treated for stenosis in the iliac artery using a gore® viabahn® vbx balloon expandable endoprosthesis.It was reported the stent graft separated from the catheter while being advanced through the patient iliac artery.The physician stated the cause was the anatomy was heavily calcification.A snare catheter was used to remove the fully constrained stent through the sheath.Another gore device was used to complete the procedure.
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.

• 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: 11039624
• Report Number: 2017233-2020-01551
• Device Sequence Number: 1256763
• Product Code: PRL
• UDI-Device Identifier: 00733132637515
• UDI-Public: 00733132637515
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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
• Report Date (Section B): 01/22/2021

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: 06/03/2022
• Device Model Number: BXA072902A
• Device Catalogue Number: BXA072902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1