BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2050745 · Received March 31, 2011

    Report

    Report Number
    9612164-2011-00137
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (STENT DISLODGEMENT), (EXCESSIVE VESSEL TORTUOSITY AND SEVERE LESION CALCIFICATION). CONCLUSION: (EXCESSIVE VESSEL TORTUOSITY AND SEVERE LESION CALCIFICATION).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DELIVER A DRIVER SPRINT RX BARE METAL STENT 2.75MM DIAMETER 12MM LENGTH TO THE DISTAL LAD. HOWEVER, THE RELEVANT STENT FAILED TO REACH THE TARGET LESION. THE PHYSICIAN SUCCEEDED TO CROSS THE LESION WITH THE BALLOON, BUT FAILED TO CROSS THE OTHER DEVICES. AS THE DISTAL SIDE OF THE LEFT MAIN TRUNK WAS NARROWED, THE PROXIMAL SIDE OF THE SDS BALLOON WAS INFLATED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE RELEVANT DEVICE. THE STENT DISLODGED ONTO THE GUIDEWIRE AND MOVED TO THE DISTAL SIDE. PHYSICIAN WITHDREW THE STENT INTO THE INTRODUCER SHEATH AND CUT DOWN THE PUNCTURE SITE TO TAKE OUT THE DISLODGED STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER SPRINT RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0004910451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention