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

Model Number 22437-19

Device Problems Break (1069); Off-Label Use (1494); Material Split, Cut or Torn (4008)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported break was not confirmed; however, a tear was observed on the pod which was likely the intended damage being reported.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 similar incidents and/or complaints reported from this lot.As it was reported that the emboshield nav6 eps was being used to treat the left vertebral artery, it should be noted that the emboshield nav 6 instruction for use states: the emboshield nav6 rapid exchange (rx) embolic protection system is a temporary percutaneous transluminal filtration system designed to be used as a guide wire and to capture embolic material released during an angioplasty and stent procedure within a saphenous vein bypass graft or a carotid artery.In this event, there was no patient involvement.The investigation was unable to determine a conclusive cause for the reported difficulty.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing the pod to tear; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that the procedure was to treat the left vertebral artery with 80% stenosis.During preparation of the emboshield nav6 embolic protection system (eps), the delivery catheter pod was noted to have a cosmetic crack.The device was not used and there was no patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a torn delivery catheter pod.

• 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: 12387800
• MDR Text Key: 270501511
• Report Number: 2024168-2021-07636
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0072861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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