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

Catalog Number 22442-19

Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920); Migration (4003)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 60% stenosed, de novo lesion in the carotid artery.The nav6 emboshield was advanced distal to the lesion and parked in the appropriate place.An attempt was made to advance the barewire, but the wire became stuck, either on the delivery catheter or on the filter.The lesion was dilated with a non-abbott balloon and a non-abbott stent was implanted and post dilated.There was a lot of movement on the wire while replacing the stent delivery catheter with a balloon dilatation catheter and it was noted that the filter moved from its parking location further into the vessel.An attempt was made to position the retrieval catheter to retrieve the filter, but before reaching the stenting area, the guide catheter slipped out of the vessel and could not be placed there again.The opened emboshield was retrieved by pulling it through the stent until it reached the tip of the retrieval catheter and pulled in.The retrieval catheter was pulled out with the barewire.The device was examined once removed from the anatomy and the filter could not be seen as it was stuck in the catheter 3 to 4cm from the distal tip.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Incorrect removal.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported difficulties were unable to be tested due to the condition of the returned unit.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 was reported that the opened emboshield was retrieved by pulling it through the stent until it reached the tip of the retrieval catheter and pulled in.It should be noted the emboshield nav6 embolic protection system electronic instructions for use (eifu) instructs to advance the retrieval catheter through the stent / treated lesion until the radiopaque catheter tip contacts the proximal end of the filtration element.In this event, it was reported that an attempt was made to position the retrieval catheter to retrieve the filter, but before reaching the stenting area, the guide catheter slipped out of the vessel and could not be placed there again.Pulling the filter through the stent until it reached the tip of the retrieval catheter seemed to be a reasonable clinical response to the difficulties encountered and does not appear to be a definitive cause for the reported difficulties encountered.Based on the information provided, the investigation determined that the reported difficulties were likely related to circumstances of the procedure.The reported difficulty advancing the barewire was likely due to interaction with the delivery catheter or on the filter during advancement.The reported filter migration appears to be due to the excessive movement encountered on the wire while replacing the stent delivery catheter with the balloon dilatation catheter.Additionally, the difficulty positioning the retrieval catheter to recover the filter was related to the guide catheter slipping out of the vessel.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: 15620077
• MDR Text Key: 302577015
• Report Number: 2024168-2022-10723
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 22442-19
• Device Lot Number: 9120261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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: ABBOTT HEAVY WEIGHT; BOSTON BALLOON; WALLSTENT