BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SPRINT RX CORONARY STENT

    MDR report key: 1822564 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01647
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS AND CONCLUSIONS: STENT ADVANCEMENT IMPAIRED BY PREVIOUSLY DEPLOYED STENT. STENT ATTEMPTED TO BE IMPLANTED THROUGH A PREVIOUSLY DEPLOYED STENT. STENT EMBOLISM.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 3.5MM DIAMETER X 24MM LENGTH DRIVER SPRINT RAPID EXCHANGE (RX) CORONARY STENT TO A LESION IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS REPORTED TO EXHIBIT 90% STENOSIS AND SOME CALCIFICATION. IT WAS REPORTED THAT THERE WAS ANOTHER STENT ALREADY PLACED IN THE SAME VESSEL, IN THE VERY PROXIMAL SEGMENT OF THE RCA. THE STENT HAD BEEN INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS ALSO CONFIRMED THAT THE LESION HAD NOT BEEN PRE-DILATED PRIOR TO THE ATTEMPTED DELIVERY OF THE DRIVER SPRINT STENT. THE ATTEMPT TO DELIVER THE STENT WAS REPORTED TO HAVE BEEN UNSUCCESSFUL - THE STENT WAS UNABLE TO CROSS THE LESION. IT WAS CONFIRMED THAT FORCE WAS USED IN THE ATTEMPT TO ADVANCE THE DEVICE NEAR THE LESION. THE PHYSICIAN THEN RETRIEVED THE DEVICE TO ENSURE THAT THE STENT WAS CORRECTLY CRIMPED TO THE DELIVERY SYSTEM. IT WAS CONFIRMED THAT THE STENT WAS CRIMPED IN THE CORRECT WAY. A SECOND ATTEMPT WAS THEN MADE TO DELIVER THE STENT. IT WAS REPORTED THAT DURING THE ATTEMPT TO REACH THE LESION THE STENT DISLODGED FROM THE BALLOON OF THE DELIVERY SYSTEM IN THE PROXIMAL RCA (WHERE THE PREVIOUSLY DEPLOYED STENT HAD BEEN PLACED). THE DISLODGED STENT WAS RETRIEVED WITH OTHER DEVICE AND THE LESION WAS TREATED WITH A NON-MEDTRONIC STENT. PT STATUS POST-PROCEDURE WAS REPORTED TO BE GOOD AND NO OTHER CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER SPRINT RX CORONARY STENT MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0002385562

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention