BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1760602 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01317
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 16, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (HIGH CALCIFICATION, STENOSIS). (BALLOON INFLATED TO PRESSURE ABOVE RATED BURST PRESSURE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0MM DIAMETER X 15MM LENGTH DRIVER RAPID EXCHANGE (RX) CORONARY STENT IN A PATIENT. THE TARGET LESION LOCATED IN THE LM, WAS DESCRIBED AS HIGHLY CALCIFIED WITH 95% STENOSIS AND WAS PRE DILATED. IT WAS REPORTED THAT PRIOR TO THIS SEVERAL ATTEMPTS WERE MADE TO DEPLOY OTHER STENTS BUT ALL THIS ATTEMPTS FAILED DUE TO THE HIGH CALCIFIED VESSEL. HOWEVER, IT WAS REPORTED THAT, AFTER CROSSING THE LESION, WHEN THE BALLOON OF RELEVANT DEVICE WAS INFLATED TO 22-23 ATMS, RUPTURED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE PT THEREFORE, THE PT WAS SENT FOR SURGICAL PROCEDURE FOR REMOVAL. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0002321320

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention