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

Model Number VBH091502A

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

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 Description

The following information was reported to gore: on (b)(6) 2020, the patient underwent treatment of a popliteal aneurysm using gore® viabahn® endoprosthesis.During deployment of the viabahn the deployment line broke leaving a portion of the device constrained.It was reported as the delivery system was removed from the patient the stent graft completely expanded.However, a portion of the deployment line was left in the patient.The physician stated the suspected cause of the deployment line break is unknown.The patient tolerated the procedure.

Manufacturer Narrative

Engineering evaluation task was performed and the results are: the deployment knob, deployment line, and delivery catheter were returned.The deployment line appeared to be broken and was returned in two sections.The first section was attached to the deployment knob and measured approximately 155 cm with a 10 cm single fiber at the end of the line, see returned sample image (2).The second section measured approximately 24 cm with a 65 cm single fiber at one of the ends, see returned sample image (3).The delivery catheter was unremarkable.Engineering evaluation conclusion(s) are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected - common device name.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10374625
• MDR Text Key: 205979345
• Report Number: 2017233-2020-01093
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623198
• UDI-Public: 00733132623198
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: VBH091502A
• Device Catalogue Number: VBH091502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 12/02/2020
• Supplement Dates FDA Received: 09/02/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1