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

Catalog Number 22438-19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Visual Disturbances (2140)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of embolism and visual disturbance are listed in instructions for use emboshield nav6 embolic protection system as a known patient effect(s) of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a calcified lesion in the carotid artery.The filter of an emboshield nav6 embolic protection system (eps) was successfully deployed distal to the lesion.Shock wave therapy was performed with a shock wave balloon catheter and an unspecified stent was successfully deployed.The patient developed sudden onset of blurred vision and sight loss in the right eye.An emboli was noted to have bypassed the filter and caused an occlusion in one of the optical arteries.Tissue plasminogen activator (tpa) was administered directly to the clot percutaneously.The clot dissipated and while there was a marked improvement in the patient's vision, some blurriness remained.There was no stroke diagnosis given.There was no reported problem or break with the filter of the eps and wall apposition was reported to be good.The physician thought that the emboli bypassing the stent could have been caused by the shock wave balloon therapy and the vibration that this causes.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: connie speck ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8865236
• MDR Text Key: 153407032
• Report Number: 2024168-2019-10596
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 22438-19
• Device Lot Number: 9060661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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
• Patient Outcome(s): Required Intervention