BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1914273 · Received November 30, 2010

    Report

    Report Number
    2953200-2010-02356
    Event Type
    Death
    Date Received
    November 30, 2010
    Date of Event
    September 23, 2010
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (AMI, IDDM, HP, HL, CEREBRAL STROKE AND ABNORMAL RENAL FUNCTION). (DEATH). CONCLUSIONS: (PT'S CONDITION PREDISPOSED EVENT).

    Additional Manufacturer Narrative · 1

    DURING THE INDEX PROCEDURE LAD WAS ALSO TREATED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SITE OF LESION TREATED DURING INDEX PROCEDURE WAS THE LEFT MAIN NOT THE FIRST RIGHT LATERAL AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED A 3.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE 1ST RIGHT LATERAL, FOLLOWING PRE-DILATATION OF THE LESION WITH A 3.0 MM DIAMETER X 15 MM LENGTH BALLOON. FOLLOWING POST-DILATATION, 0% STENOSIS REMAINED. AFTER PRE-DILATATION, VESSEL DISSECTION OCCURRED AND PERIPHERAL EMBOLISM WAS CONFIRMED, WHICH WAS IMPROVED BY INTRACORONARY INJECTION WITH NICORANDIL. APPROX TWO WEEKS POST-INDEX PROCEDURE, THE PT PASSED AWAY DUE TO CARDIAC AND RENAL FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death ASPIRIN