BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3003951 · Received March 14, 2013

    Report

    Report Number
    9612164-2013-00288
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    September 29, 2009
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED TO OPERATIONAL CONTEXT-DIFFICULT VESSEL MAY HAVE CONTRIBUTED TO OPERATIONAL CONTEXT. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-DISSECTION. OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT-DIFFICULT VESSEL MAY HAVE CONTRIBUTED TO OPERATIONAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    A SHORT PRO-WATER WIRE WAS USED TO CROSS THE LESION. THE LESION IN THE LAD WHICH EXHIBITED 90% STENOSIS WAS PRE-DILATED USING A 2 X 15 MM SPRINTER BALLOON AT 9 ATMOSPHERES. A NON -MEDTRONIC STENT WAS DEPLOYED AT THE LESION AT 8 ATMOSPHERES. THE STENT WAS POST-DILATED USING A 2 X 15 MM SPRINTER BALLOON. AT THIS TIME, A DISSECTION WAS NOTED AT THE DISTAL EDGE OF THE STENT, WHICH WAS NON-FLOW-LIMITING. THE PHYSICIAN WAS NOT ABLE TO DELIVER A SECOND STENT THROUGH THE NEWLY DEPLOYED STENT. FINAL ANGIOGRAM SHOWS TIMI-III FLOW, STABLE DISSECTION, RESIDUAL 0% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107777 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention