BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER MX2 CORONARY STENT SYSTEM

    MDR report key: 1021229 · Received March 28, 2008

    Report

    Report Number
    2953200-2008-00166
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERE CALCIFICATION WITH 95% STENOSIS). INHERENT RISK OF PROCEDURE (STENT EMBOLIZATION). FAILURE TO FOLLOW INSTRUCTIONS (ADVANCING STENT THROUGH PREVIOUSLY DEPLOYED STENT) CONCLUSIONS - DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (SEVERE CALCIFICATION WITH 95% STENOSIS). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (ADVANCING STENT THROUGH PREVIOUSLY DEPLOYED STENT).

    Description of Event or Problem · 1

    AN UNK SIZE DRIVER MXII CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN RCA LESION. THE VESSEL MORPHOLOGY WAS SEVERELY CALCIFIED WITH 95% STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE SDS WAS INSERTED AND WHILE PASSING THROUGH A PREVIOUSLY DEPLOYED STENT, THE STENT DISLODGED. THE UNDEPLOYED STENT TRAVELED TO THE LEG; THE STENT WAS SNARED AND REMOVED FROM THE PT SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER MX2 CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention