BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3121637 · Received May 21, 2013

    Report

    Report Number
    9612164-2013-00554
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE. (ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO PATIENT LESION MORPHOLOGY). INHERENT RISK OF PROCEDURE. (CORONARY VESSEL DISSECTION, PERFORATION, RUPTURE OR INJURY ARE LISTED IN THE PRODUCT IFU AS INHERENT RISKS ASSOCIATED WITH CORONARY BALLOONING PROCEDURES). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION.(ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO PATIENT LESION MORPHOLOGY). INHERENT RISK OF PROCEDURE ¿ (CORONARY VESSEL DISSECTION, PERFORATION, RUPTURE OR INJURY ARE LISTED IN THE PRODUCT IFU AS INHERENT RISKS ASSOCIATED WITH CORONARY BALLOONING PROCEDURES). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THE PHYSICIAN WAS ATTEMPTING TO INFLATE A 3.0 X 15MM SPRINTER LEGEND BALLOON IN A HEAVILY CALCIFIED LESION IN RCA. IT IS REPORTED THAT THE BALLOON BURST AT 12ATM WHICH IS BELOW IT¿S RBP OF 14ATM RESULTING IN A VESSEL DISSECTION. THE PHYSICIAN INDICATED THAT THE EVENT COULD HAVE BEEN DUE TO THE CALCIFICATION. SUBSEQUENTLY, A 3.0 X 12MM NC SPRINTER BALLOON WAS USED SUCCESSFULLY FOR POST DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223700 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 206347082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention