BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM

    MDR report key: 1933801 · Received December 13, 2010

    Report

    Report Number
    2025587-2010-00163
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC HEART VALVE, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL METHOD = DEVICE HISTORY REVIEWED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION = CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. W/O THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFO THAT DURING THE PLACEMENT OF THIS TRANSCATHETER VALVE, AFTER THE SECOND DILATION OF THE OUTER BALLOON; THE BALLOON RUPTURED. THE DELIVERY SYSTEM WAS PULLED BACK, BUT THE OUTER BALLOON WAS UNABLE TO BE REMOVED FROM THE LEFT FEMORAL VEIN SECONDARY TO NOT BEING RE-SHEATHED BY THE DELIVERY SYSTEM. THE OUTER BALLOON AND THE TIP WERE REMOVED AFTER THE DELIVERY SYSTEM WAS DECONSTRUCTED USING A SMALL MOSQUITO SURGICAL CLAMP. ONCE REMOVED, THE PUNCTURE SITE WAS CLOSED. THERE WERE NO ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM NPV MEDTRONIC HEART VALVE, INC. NU 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention