MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAJ052502E

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.

Event Description

It was reported that on an unknown date, the patient was intended to be treated with a gore® viabahn® endoprosthesis.It was reported that the deployment line ¿was cut off¿ in the middle of the deployment.The physician solved the issue and the patient tolerated the procedure.

Manufacturer Narrative

Patient identifier: updated.Date of event: updated.Event: updated.Corrected combination product.Updated method, result and conclusion codes.The deployment line, deployment knob, and delivery catheter were returned to w.L.Gore & associates for evaluation.The following observations were made: there was approximately 177 cm of deployment line returned including a 9.5 cm single fiber on the end of the deployment line.The dual lumen appeared to be cut 30 cm from the hub.The remainder of the device appeared to be unremarkable.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Event Description

It was reported that on (b)(6) 2020, the patient presented with femoropopliteal occlusion in the left leg that was treated with the implantation of a gore® viabahn® endoprosthesis (vb).The vb was advanced antegrade over a 0.0018¿ terumo glidewire advantage guidewire through a 6f cordis brite-tip sheath.It was stated that the vb easily passed a 3 mm predilated long ¿semifresh¿ occlusion.The vb was easily positioned with the distal end in the popliteal artery without friction or resistance.During the deployment of the vb, the deployment line separated after approx.10 cm stent deployment.The physician stated that it was unsuccessfully tried to retrieve the deployment line by taking apart the delivery system.Therefore a long sheath was introduced over the catheter and it was managed to deploy the vb by retracting the catheter in increments while holding some forward pressure on the introducer sheath.At the end of the procedure the vb was deployed at the intended position and the procedure successfully completed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9942108
• MDR Text Key: 195589533
• Report Number: 2017233-2020-00239
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAJ052502E
• Device Lot Number: 20764861
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 77