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

Catalog Number 22443-19

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, heavily calcified and mildly tortuous vessel in the common femoral artery.The emboshield nav 6 was prepared per instructions for use (ifu) and the placing of the filter and the procedure went very well.However, upon removal, the captured filter that was already inside the retrieval catheter could not retract through the sheath (guiding catheter).The physician used more force to retract it and was finally able to remove the retrieval catheter together with the barewire.It was then noted that the retrieval catheter was kinked at the rx guide wire exit port.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficult to remove was not confirmed due to the condition of the returned device.The damage to the retrieval catheter 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 revealed no other complaints reported from this lot.It should be noted that the emboshield nav 6 instructions for use states: ¿if significant resistance is felt, retract the guide catheter or sheath and the retrieval catheter together.¿ although it was reported that extra force was used to remove the retrieval catheter, the excess force seemed to be a reasonable clinical response to the difficulties.The investigation determined that the reported difficulties were related to circumstances of the procedure.The difficulty removing the retrieval catheter into the guide catheter was likely due to the kink noted on the retrieval catheter at the exit port.The kink to the retrieval catheter likely occurred during positioning and retrieval of the filtration element.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

• 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: 13587889
• MDR Text Key: 287323033
• Report Number: 2024168-2022-01930
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 1102061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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: BAREWIRE; GUIDING CATHETER