BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1031177 · Received April 18, 2008

    Report

    Report Number
    2953200-2008-00232
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    July 17, 2007
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- INHERENT RISK OF PROCEDURE (STENT THROMBOSIS/OCCLUSION). OTHER, LACK OF INFO). CONCLUSION - (LACK OF INFO). (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    PT HAD BEEN TREATED FOR HYPERTENSION. ONE LESION WAS TREATED 18 MONTHS AGO WITH ONE ENDEAVOR STENT. MEDICATIONS PRESCRIBED AT THE DAY OF PROCEDURE WERE AS FOLLOWS: ASPIRIN = 500MG; CLOPIDOGREL = 600MG. THE LESION TREATED WAS LOCATED IN THE PROXIMAL LAD. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (3.0X30MM STENT). NINE MONTHS AGO THE PT SUFFERED A NON-Q WAVE MI. REVASCULARIZATION WAS PERFORMED ON THIS DATE (PTCA). THE LOCATION OF THE REVASCULARIZATION WAS THE MID-LAD. THE INVESTIGATOR STATED THAT THERE WAS A DEFINITIVE RELATIONSHIP BETWEEN THE EVENT AND THE ENDEAVOR DEVICE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention