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

Model Number 22438-19

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to a lesion in the right internal carotid artery.The emoboshield nav6 embolic protection system (eps) was placed on the wrong guide wire and as a result the filter came off during the procedure.The filter migrated to the internal carotid artery.A snare device was used to retrieve the filter.An unspecified device was used to successfully complete the procedure.A clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 similar complaints reported from this lot.Based on the information provided, the investigation determined that the reported difficulties were user related.Failing to use the provided barewire filter delivery wire as instructed in the product instruction for use resulted in the filter coming off the non-abbott guide wire resulting in migration of the filter.It should be noted the emboshield nav6 embolic protection system electronic instructions for use (ifu) warns: the emboshield nav6 device can only be used with the barewire filter delivery wire.Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed medwatch report, additional information was received.The nav6 device was used on a non-abbott guide wire.Once the filter was retrieved, the procedure was completed using a new nav6.No additional information was provided.

• 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
• MDR Report Key: 10906964
• MDR Text Key: 218494269
• Report Number: 2024168-2020-09942
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0050561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 111