BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2181159 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00827
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 3, 2013
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION, STENT THROMBOSIS). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION, STENT THROMBOSIS). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (STENT THROMBOSIS/MI/REVASCULARISATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 28 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO AN MI AND STENT THROMBOSIS IN THE LAD. THE PATIENT UNDERWENT AN ASPIRATION THROMBECTOMY AND BALLOON TREATMENT. THE OUTCOME WAS RESOLVED. THE INVESTIGATOR ASSESSED THAT THE EVENTS WERE DEFINITELY RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PT WAS RE-HOSPITALIZED. RE-PTCA WAS PERFORMED (BALLOONING) DUE TO THROMBOSIS. THROMBOSIS CONFIRMED BY ACUTE CORONARY SYNDROME/ANGIOGRAPHIC CONFIRMATION OF STENT THROMBOSIS OR OCCLUSION. ASSOCIATED CLINICAL SYMPTOMS MYOCARDIAL INFARCTION. THE INVESTIGATOR INDICATED THAT ALL EVENTS WERE DEFINITELY RELATED TO THE STUDY DEVICE/PROCEDURE.

    Description of Event or Problem · 1

    THROMBECTOMY WAS ALSO PERFOMRED TO TREAT THE PREVIOUSLY REPORTED THROMBOSIS EVENT WHICH OCCURRED APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED MI WHICH OCCURRED 5 MONTHS POST INDEX PROCEDURE WAS RELATED TO THE TARGET VESSEL. THE PREVIOUSLY REPORTED PTCA WHICH OCCURRED 5 MONTHS POST INDEX PROCEDURE WAS TO TREAT THE TARGET LESION. THE OUTCOME OF THE PTCA WAS SUCCESSFUL. THE PREVIOUSLY REPORTED STENT THROMBOSIS WHICH OCCURRED 5 MONTHS POST INDEX PROCEDURE OCCURRED IN THE LAD. THE PREVIOUSLY REPORTED MI WHICH OCCURRED 28 MONTHS POST INDEX PROCEDURE WAS RELATED TO THE TARGET VESSEL. THE PREVIOUSLY REPORTED PTCA WHICH OCCURRED 28 MONTHS POST INDEX PROCEDURE WAS TO TREAT THE TARGET LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001060403

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LIPID LOWERING DRUGS| CLOPIDOGREL| ASA| ANGIOTENSIN II RECEPTOR ANTAGONIST