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

Model Number 22438-19

Device Problems Off-Label Use (1494); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified superficial femoral artery.The emboshield nav6 embolic protection system (eps) was prepared with original bare wire however, the physician decided to back load a non-abbott guide wire instead.The eps was advanced past the lesion with resistance felt with anatomy.The eps was attempted to be deployed; however, it only partially deployed.During the process to deploy, the delivery sheath separated and the filter popped out.The separated portion of the delivery sheath was retrieved; however, it is unknown how the separated portion was retrieved.The filter was retrieved via snare.The patient is doing well and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Medical device problem code (b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The udi is unknown because the lot number was not 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 indication of a lot specific product quality issue.It should be noted the emboshield nav6 embolic protection system electronic instructions for use 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.In this case, it could not be determined if use of the non-abbott wire caused or contributed to the difficulty.Based on the information provided, the investigation was unable to determine a cause for the reported difficulties resulting in unexpected medical intervention to remove the separated portion of the delivery catheter pod.It may be possible that during advancing against resistance with the anatomy, damage to the delivery catheter pod occurred and when the attempt was made to deploy the filter the pod separated as a result of the damage causing the filter to partially deploy.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3: date of event updated to 6/14/2022.D9/h3: device return status updated.H6: medical device problem code 1494- incorrect anatomy was removed.H6: medical device problem code 2017 was inadvertently left off of the initial report.

Event Description

This event has been determined to be a duplicate of (b)(4) (previously filed under mfr report ref# 2024168-2022-08552-01) the user facility medwatch report was received under the duplicate event and states "abbott emboshield nav6 embolic protection system detached in pt.Physician had to use snare device to remove detached portion from pt.Device given to dept mgr.Factual description per event summary, surgeon confirmed no harm or detrimental impact to pt regarding this device failure.Also, confirmed that device in its entirely was successfully removed.Physician indicated this is an isolated incident.He has done thousands of these procedure with this device.This is the first instance he has encountered.He also indicated that the pt's anatomy (angle of aortic bifurcation} necessitated a sharper turn through the aortic bifurcation while using the device.Physician believed this is a "one-off" situation".Additionally, subsequent to filing the initial report, the following additional information was received: per the account, atherectomy was performed to complete the procedure.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
• 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: 14931724
• MDR Text Key: 295336215
• Report Number: 2024168-2022-07204
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• 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,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 1102961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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
• Treatment: VIPER WIRE
• Patient Outcome(s): Required Intervention