MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Model Number 22437-19

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately calcified, heavily tortuous lesion in the internal carotid artery.An emboshield nav6 embolic protection system (eps) was advanced; however, it could not pass due to the tortuous anatomy.During removal of the device, the tip of the barewire separated and migrated to the external carotid artery.The tip of the wire was not attempted to be retrieved and remains free floating in the patient.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.

Manufacturer Narrative

Medical device problem code 2017 clarifier: incorrect removal the device was not returned for analysis.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 revealed no other complaints reported from this lot.Reportedly, force was applied against resistance during removal form the anatomy.It should be noted that the emboshield nav 6 instructions for use states: ¿do not continue to retract the barewire filter delivery wire against significant resistance.¿ the investigation determined the reported failure to advance, tip separation and difficult to remove appear to be related to case circumstances of the procedure.In this case, based on the reported information.The emboshield nav6 embolic protection system (eps) failed to cross and was difficult to remove due to the challenging tortuous anatomy.The manipulation during retraction ultimately resulted in the reported tip separation.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15677564
• MDR Text Key: 302468555
• Report Number: 2024168-2022-11075
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 2072561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other