BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2223885 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00958
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ROOT CAUSE UNKNOWN, DEVICE OR THE PROCEDURAL IMAGES HAVE NOT BEEN PROVIDED FOR REVIEW. CORONARY VESSEL DISSECTION. EVALUATION, CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ONE ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD WITH NO ISSUES. THE NEXT LESION TARGETED WAS THE COMPLEX CALCIFIED DISTAL CIRCUMFLEX (LCX) ARTERY STENOSIS. THERE WAS 96% STENOSIS IN THE LESION WITH TIMI 1 FLOW. A 0.014" GUIDEWIRE SUPPORTED BY A GUIDING CATHETER WAS SUCCESSFULLY USED TO CROSS THE STENOSIS. ATTEMPTS TO PREDILATE THE DISTAL LCX LESION USING THREE DIFFERENT NON-MEDTRONIC BALLOONS WERE UNSUCCESSFUL. A CATHETER WAS THEN USED TO CROSS THE DISTAL LCX LESION, FURTHER DILATION WITH A 2.25X15MM SPRINTER LEGEND BALLOON AND A 2.25X15MM NON-MEDTRONIC BALLOON RESULTED IN A GRADE A DISSECTION OF THE CIRCUMFLEX ARTERY. THE DISSECTION WAS NOT TREATED. A DECISION WAS MADE TO ABORT THE DISTAL LCX STENOSIS PCI AND TO TARGET THE 1ST OBTUSE MARGINAL (OM1) STENOSIS INSTEAD. AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT WAS IMPLANTED IN THE OM1 WITH NO ISSUES. FOLLOWING ANGIOGRAPHIC CONFIRMATION OF A SATISFACTORY RESULT, THE PROCEDURE WAS TERMINATED AND THE PATIENT TRANSFERRED TO (B)(6) FOR POST-PROCEDURAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC TIJUANA NA 10958757

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization