MAUDE Adverse Event Report: ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM

Model Number 22440-31

Device Problem Material Separation (1562)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The nav6 filter is being filed under a separate medwatch number.

Event Description

It was reported that the procedure was to treat an artery in the lower extremities.The emboshield nav6 embolic protection device (epd) and the barewire were placed and then the patient received atherectomy in the vessel.When the filter was attempted to be retrieved, it was noted that the tip of the barewire had detached and had moved to a side branch of the peroneal artery.A snare was used to retrieve the filter; however, the tip of the barewire remains in the patient.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints.The investigation was unable to determine a cause for the reported tip separation.It may be possible that interaction between the barewire and atherectomy device caused the tip to separate.It may also be possible that the tip of the barewire became lodged within a tight vessel resulting in separation during removal; however, this could not be confirmed.Embolism is listed in the emboshield nav6 embolic protection system electronic instructions for use as a known potential adverse event potentially associated with carotid stents and embolic protection systems.The reported embolism and foreign body in patient were related to circumstances procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10744291
• MDR Text Key: 213410711
• Report Number: 2024168-2020-08946
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: 08717648137808
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 9120361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6 FILTER; JETSTREAM ATHERECTOMY; EMBOSHIELD NAV6 FILTER; JETSTREAM ATHERECTOMY
• Patient Outcome(s): Other