MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV 6; EMBOLIC PROTECTION SYSTEM

Catalog Number 22445-31

Device Problems Entrapment of Device (1212); Off-Label Use (1494); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during an atherectomy case in the superficial femoral artery, the barewire of the emboshield nav6 system separated inside the anatomy.A snare was used to retrieve the separated portion as well as the filter of the emboshield nav6.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record for this product could not be reviewed and a similar complaint query could not be performed because the lot number was not reported.The nav6 instruction for use states: the emboshield nav6 rapid exchange (rx) embolic protection system is a temporary percutaneous transluminal filtration system designed to be used as a guide wire and to capture embolic material released during an angioplasty and stent procedure within a saphenous vein bypass graft or a carotid artery.In this case, the off-label use of the emboshield nav6 in the superficial femoral artery does not appear to have contributed to the difficulties.The investigation determined that the reported difficulties were related to circumstances of the procedure.Based on the reported information, interaction between the barewire tip and the atherectomy device caused the devices to become entangled and the tip of the barewire separated.Reportedly, a snare was used to retrieve the separated portion as well as the filter of the emboshield nav6.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional reported information indicates that the emboshield nav6 deployed correctly and there was no resistance during advancement.Additionally, retrograde access was performed and accessed with a 4fr sheath positioned distal to the barewire tip.During atherectomy, the barewire tip came into contact with the distal sheath, causing a loop and the wire to be anchored to the sheath.The atherectomy device jammed on the wire and caused the wire to spin, damaging the distal tip and causing it to break.The separated barewire tip was removed with the distal sheath and the body of the barewire was removed with the proximal sheath.The filter was then snared and removed from the patient.No additional information was provided.

• Brand Name: EMBOSHIELD NAV 6
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9747694
• MDR Text Key: 182326853
• Report Number: 2024168-2020-01741
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22445-31
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FR SHEATH; JETSTREAM ATHERECTOMY DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR