MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; MULTIPLE PERIPHERAL ARTERY STENT, BARE-METAL

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Occlusion (1984); Vascular Dissection (3160)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

The other device involved in this incident was reported under 2017233-2020-01063, identified as (b)(4).The device is assumed to be a combination product, although the implantation timeframe and lot number is unknown.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: in a literature article titled "an anomalous mechanism causing failure of expanded polytetrafluoroethylene-covered nitinol stents, evaluated using multiple intravascular imaging modalities" it states a patient underwent treatment of a right superficial femoral artery (sfa) lesion with bare metal stents on two separate occasions.However he developed right lower limb claudication one year after the initial procedure.Angiography showed right sfa occlusion with multiple stent fractures.Two gore® viabahn® endoprostheses were implanted as well as an additional bare metal stent.Patency was restored.On an unknown date a year following implantation of the viabahn devices the patient presented with severe right limb ischemia.Initial angiography showed flow disturbance in the right sfa.Intravascular ultrasound and optical coherence tomography showed an arterial dissection¿like double-lumen structure with a pulsatile flap inside the stents.Angioscopy revealed a white pulsatile structure that looked like an artificial wall.Optimal arterial flow was obtained by placing 2 bare-metal stents inside the viabahn stents.Kobayashi n, takano m, miyauchi y, shimizu w.An anomalous mechanism causing failure of expanded polytetrafluoroethylene-covered nitinol stents, evaluated using multiple intravascular imaging modalities.Jacc: cardiovascular interventions 2020;13(8):e73-e75.

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.

Manufacturer Narrative

Updated h.6.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: MULTIPLE PERIPHERAL ARTERY STENT, BARE-METAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10341778
• MDR Text Key: 201540817
• Report Number: 2017233-2020-01064
• Device Sequence Number: 1
• Product Code: PFV
• 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,litera
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention