BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 4240860 · Received November 10, 2014

    Report

    Report Number
    2025587-2014-00867
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED CLINICAL OBSERVATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. FROM THE AVAILABLE INFORMATION A CONCLUSIVE CAUSE FOR THE OCCLUSION COULD NOT BE DETERMINED. HOWEVER, THIS ISSUE IS MOST LIKELY THE RESULT OF PATIENT CONDITION. WITHOUT ADDITIONAL INFORMATION WE ARE UNABLE TO DETERMINE IF THE DELIVERY CATHETER SYSTEM (DCS) OR THE SHEATH CONTRIBUTED TO DISLODGING THE PLAQUE IN THE PATIENT'S ARTERY DURING REMOVAL.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE 18FR SHEATH WAS REMOVED AND A LARGE POSTERIOR PLAQUE WAS NOTICED THAT HAD BEEN ELEVATED BY THE SHEATH. AN EXTENSIVE THROMBOENDARTERECTOMY OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED. THE ARTERY WAS REPAIRED AND THERE WAS EXCELLENT PULSE AFTER COMPLETION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722773 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 00087 YR Required Intervention