MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV 6; EMBOLIC PROTECTION SYSTEM

Catalog Number 22443-19

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Visual, dimensional and functional analysis performed on returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation was unable to determine a conclusive cause for the reported difficulty to insert.It may be possible that the filter was pulled into the pod too quickly.Additionally, it may be possible that the difficulty was related to the loading tray; however, without having the tray to examine, this could not be confirmed.Although there is no indication of a product quality issue with respect to manufacture, design or labeling for the returned components, an investigation will be conducted regarding recent incidents of difficulty to insert (load) the emboshield nav6 device.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

It was reported that during preparation of an emboshield nav6 embolic protection system (eps) the filter could not be inserted into the delivery catheter pod.The delivery catheter pod was wrinkled.The eps was not used and there was no patient involvement.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 returned device analysis identified a vertical tear in the filter membrane proximal to the filter support structure assembly for a length of 1.5mm.No additional information was provided.

• Brand Name: EMBOSHIELD NAV 6
• 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: 9706445
• MDR Text Key: 179280657
• Report Number: 2024168-2020-01457
• 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
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 22443-19
• Device Lot Number: 8082961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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