BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1990323 · Received February 9, 2011

    Report

    Report Number
    2953200-2011-00322
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: HOMODYNAMIC FAILURE, STENT DISLODGEMENT AND ANTI PLATELET THERAPY WHICH WAS CONTINUED TO DOSE AND NOT CHANGED TO ANOTHER. STENT THROMBOSIS & DEATH. EVALUATION CONCLUSION: HOMODYNAMIC FAILURE, STENT DISLODGEMENT AND ANTI PLATELET THERAPY WHICH WAS CONTINUED TO DOSE AND NOT CHANGED TO ANOTHER.

    Description of Event or Problem · 1

    KISSING STENT TECHNIQUE WAS ATTEMPTED WITH TWO ENDEAVOR SPRINT 3.0MM DIAMETER X 15MM LENGTH RAPID EXCHANGE (RX) DRUG ELUDING STENTS IN THE LMT-LAD AND LMT-LCX. THE LESION IN THE LCX HAD NOT BEEN PRE-DILATED, RESISTANCE WAS NOTED DURING DELIVERY AND FORCE WAS APPLIED. THIS STENT WAS DISLODGED AT ABOUT 3MM DISTAL FROM THE ORIGINAL TARGET LESION ((B)(4)). BEFORE DELIVERING A GOOSENECK SNARE TO REMOVE THE STENT, A GUIDE WIRE AT THE LAD SIDE WAS REMOVED BECAUSE TWO WIRES COULD BE TANGLED. THE GUIDE CATHETER WAS REPLACED WITH LAUNCHER (B)(4). AN ATTEMPT WAS MADE TO CATCH THE DISLODGED STENT WITH A SNARE; HOWEVER, THE SNARE WAS UNABLE TO CROSS. AN ENDEAVOR SPRINT 3.0MM DIAMETER X 9MM LENGTH RX DRUG ELUDING STENT WAS FINALLY DEPLOYED IN THE LCX CRUSHING THE DISLODGED STENT AGAINST THE VESSEL WALL. THE INITIAL STENT PLACED IN THE LAD WAS ALSO DEPLOYED WITH NO ISSUES NOTED AND GOOD DILATATION WAS CONFIRMED ON ANGIOGRAPHY. IT WAS CONFIRMED THAT 3 DAYS POST THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. CORONARY ANGIOPLASTY WAS PERFORMED, THROMBUS WAS FOUND TO HAVE FORMED AND THE RESPONSIBLE LESION COULD NOT BE IDENTIFIED. THE PATIENT DIED (REF MFR # 2953200-2011-00321 AND 2953200-2011-00323).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R PLETAAL