BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3981804 · Received August 5, 2014

    Report

    Report Number
    2025587-2014-00547
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    December 15, 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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW FOR THE DEVICE IS NOT REQUIRED AS THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. THERE WAS NO ALLEGATION AGAINST THE DEVICE AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. FROM THE LIMITED INFORMATION AVAILABLE, NO CONCLUSIVE CAUSE COULD BE DETERMINED. POTENTIAL FACTORS THAT COULD IMPACT THIS EVENT INCLUDE PATIENT ANATOMY, USER TECHNIQUE, INCOMPLETE EXPANSION OF THE ORIGINAL VALVE, ETC. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DCS WAS NOT RETURNED FOR ANALYSIS, AS THERE WAS NO ALLEGATION OF A MANUFACTURING OR FUNCTIONALITY ANOMALY. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. A SEPARATE REPORT HAS BEEN FILED AGAINST THE VALVE FOR THE POST-IMPLANT PARAVALVULAR LEAK. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS DELIVERY CATHETER SYSTEM (DCS) WAS BEING USED TO POSITION A TRANSCATHETER BIOPROSTHETIC HEART VALVE FOR IMPLANT INTO ANOTHER TRANSCATHETER BIOPROSTHETIC VALVE WHEN IT BECAME CAUGHT ON THE FRAME OF THE FIRST VALVE, PUSHING IT INTO THE LEFT VENTRICLE. THE DCS AND UN-DEPLOYED VALVE WERE WITHDRAWN, AND A SNARE WAS USED TO PULL THE FIRST VALVE UP. THE SECOND VALVE WAS THEN REINTRODUCED AND SUCCESSFULLY IMPLANTED IN A HIGHER POSITION INTO THE FIRST VALVE. A POST-IMPLANT BAV WAS PERFORMED, RESULTING IN MILD PVL. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457720 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0007068081

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention MCS-P3-31-AOA, (B)(4)