MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBHR071002A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2020
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
On (b)(6)2020, the patient was being treated for peripheral vascular disease in the external iliac using a gore® viabahn® endoprosthesis with heparin bioactive surface deployed within the sheath.It was reported the device deployed in the sheath with a small portion of the device extending outside of the sheath.The physician's suspected cause of the device deploying in the sheath is unknown.Both the sheath and device were removed from the patient.Another gore device was used to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added health effect: impact code corrected conclusion code.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11205355
• Report Number: 2017233-2021-01612
• Device Sequence Number: 2270507
• Product Code: NIP
• UDI-Device Identifier: 00733132622986
• UDI-Public: 00733132622986
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 09/06/2022
• Device Model Number: VBHR071002A
• Device Catalogue Number: VBHR071002A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1