BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1000425 · Received February 21, 2008

    Report

    Report Number
    2953200-2008-00069
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (RESISTANCE ENCOUNTERED AND FORCE EXERTED ON DEVICE). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE TORTUOSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (MODERATE TORTUOSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS). USER ERROR CONTRIBUTED TO EVENT (RESISTANCE ENCOUNTERED AND FORCE EXERTED ON DEVICE). (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 18MM LENGTH MICRO DRIVER RX CORONARY STENT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A DISTAL LAD LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOUSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS. THE LESION WAS PRE-DILATED WITH TWO BALLOONS. IT WAS REPORTED THAT THE PHYSICIAN HAD IMPLANTED ANOTHER MANUFACTURER'S DRUG ELUTING STENT FIRST IN THE PROXIMAL LAD: A SECOND DRUG ELUTING STENT FROM THE SAME MANUFACTURER WAS UNABLE TO CROSS THE LESION AFTER THAT. THE MICRO DRIVER WAS INSPECTED BY THE PHYSICIAN PRIOR TO USE AND NO ISSUES WERE NOTED. IT WAS REPORTED THAT THE PHYSICIAN THEN ATTEMPTED THE MICRO DRIVER, HOWEVER, IT WAS UNABLE TO CROSS AND WAS REMOVED. A NEW GUIDE CATHETER WAS INSERTED AND THE MICRO DRIVER WAS RE-INSERTED TO THE LESION SITE. THE STENT DELIVERY BALLOON WAS INFLATED AND AT THAT TIME THE PHYSICIAN NOTICED THE STENT WAS NOT ON THE STENT DELIVERY SYSTEM. THE PHYSICIAN PERFORMED A CONTRAST STUDY AND COULD NOT FIND THE DISLODGED STENT. THE PHYSICIAN STATED THAT THE DISLODGED STENT MIGHT BE SUBMERGED IN THE SEVERE CALCIFICATION NEAR THE LESION SITE. THE LESION SITE WAS TREATED WITH POBA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT'S STATUS IS STABLE. 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 MICRO DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0000600283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention