MAUDE Adverse Event Report: AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22438-19

Device Problems Kinked (1339); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported difficulty to remove, physical resistance and kink on the core appear to be related to circumstance of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The xact stent referenced is being filed under a separate medwatch report.

Event Description

It was reported the procedure was performed to treat a lesion in the common carotid artery.The emboshield nav 6 embolic protection system (eps) was advanced with resistance and tension noted due to the anatomy, but reached the desired location.An xact stent delivery system (sds) was advanced to the target lesion and the stent was implanted successfully.During withdrawal of the xact sds, the device became stuck with a kink in the nav 6 barewire.The distal end of the 6fr sheath was advanced up to the filter and all devices were removed as one whole system.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7375001
• MDR Text Key: 103921147
• Report Number: 2024168-2018-02232
• 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: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 22438-19
• Device Lot Number: 8011661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 95