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

Model Number	VBJR051002A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020, the patient was being implanted for an anastomosis procedure in the superior femoral artery to extended distally from a previously implanted device.During deployment it was reported the stent graft partially expanded due to the deployment line breaking.The physician stated the cause of the deployment line breaking is unknown.It was reported the patient was converted to a surgical conversion.Another device was used to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
Corrected h6 result.
Additional Manufacturer Narrative
Engineering evaluation confirms the complaint of partial deployment and finds the cause to be tensile failure of the deployment line.The ultimate cause of the broken deployment line cannot be further identified.A1 : pt id (b)(4).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN 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: 10712138
• Report Number: 2017233-2020-01375
• Device Sequence Number: 16964430
• Product Code: NIP
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 03/10/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 01/04/2021; 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention