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

Catalog Number 22443-19

Device Problems Break (1069); Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional emboshield device referenced is being filed under a separate medwatch report.

Event Description

It was reported that an emboshield nav6 embolic protection system (eps) was opened and it was noted that the deliver catheter (dc) pod was wrinkled and the filter could not be inserted into the dc pod.The eps was not used.A second emboshield nav6 eps was being prepared; however, the filter could not be inserted into the dc pod.The eps was not used.The procedure was successfully completed with a new emboshield nav6 eps.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that both eps's showed signs of use.The eps's were returned with blood on the coils and contrast on the dc pods, shafts, and coils.The return device analysis for the first eps identified that the proximal coil was separated (not in two separate pieces) 11.5mm, 12mm and 5.5cm distal to the proximal solder; however, the core was still intact.The return device analysis for the second eps identified that the dc pod was separated approximately 2.5mm distal to the marker.There was a tear on the distal separated portion of the dc pod for a length of 3.5mm.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional analysis was performed on the returned device.The reported difficult to insert was unable to be confirmed due to the condition of the returned device.The damage to the barewire likely occurred due to handling/packaging for return to abbott.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Any indication of a lot specific product issue will be addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: EMBOSHIELD NAV6
• 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: 9898076
• MDR Text Key: 185728848
• Report Number: 2024168-2020-03087
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 22443-19
• Device Lot Number: 9041161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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