BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3882240 · Received June 18, 2014

    Report

    Report Number
    2025587-2014-00407
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DISCARDED THE VALVE AND WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED AND SHOWED THAT THE DELIVERY CATHETER SYSTEM MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RE LEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE BLEEDING WAS NOTED AT THE AORTIC ACCESS POINT DURING LOOP RELEASE. DURING REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS) THE COREVALVE DISLODGED, OUT OF THE TARGETED LOCATION. IT WAS SUSPECTED THAT THE DCS TAB WAS NOT COMPLETELY FREE FROM THE VALVE FRAME LOOP UPON DCS REMOVAL. DUE TO THE CONTINUED ACCESS SITE BLEEDING AND THE DEPLOYMENT DIFFICULTY THE PATIENT WAS THEN PLACED ON BYPASS AND THE PROCEDURE WAS CONVERTED TO A SURGICAL VALVE PROCEDURE. THE TRANSCATHETER VALVE WAS SURGICALLY REMOVED FROM THE ASCENDING AORTA. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358687 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0007068084

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention (B)(4)