BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3953004 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00988
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (LESION WAS NOT PRE-DILATED). INHERENT RISK OF PROCEDURE (STENT DEFORMATION <(>&<)> ARRHYTHMIAS). PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFICATION AND 70% STENOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE, CINES NOT RETURNED). (DEVICE NOT RECEIVED) CONCLUSION CODE RESULTS; FAILURE TO FOLLOW INSTRUCTIONS (LESION WAS NOT PRE-DILATED). KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION <(>&<)> ARRHYTHMIAS). DEVICE FAILED RELATED TO PATIENT CONDITION (CALCIFICATION AND 70% STENOSIS); UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RECEIVED FOR EVALUATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN ENDEAVOR SPRINT DRUG-ELUTING STENT TO TREAT THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE PHYSICIAN WAS ATTEMPTING TO DIRECT STENT THE LESION BUT THE DEVICE WAS UNABLE THE LCX DUE TO CALCIFICATION AND 70% STENOSIS. THE DEVICE WAS REMOVED AND ON REMOVAL THE STENT WAS NOTICED TO BE DAMAGED. ANOTHER DEVICE WAS THEN USED BUT DURING EXCHANGE FOR DEVICES THE PATIENT SUFFERED A CARDIAC ARREST. THE 2ND DEVICE WAS USED SUCCESSFULLY AND THE PATIENT RECOVERED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 14TH PROXIMAL SEGMENT WAS RAISED AND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430355 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006964711

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR