BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 790652 · Received November 21, 2006

    Report

    Report Number
    6000089-2006-02480
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    October 27, 2006
    Report Date
    October 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    p020009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PCI PROCEDURE, STENT DAMAGE OCCURRED. ACCORDING TO THE CUSTOMER, "THE LESION WAS 99% OF ISR; S670 STENT WITH CALCIFICATION AND VERY TORTUOUS AT LAD MID. IT WAS INFLATED AT 20ATM WITH Q-MAV. IT FAILED TO CROSS THROUGH THE STENT. THOUGH, IT WAS TRIED SEVERAL TIMES. THE STENT EDGE GOT DEFORMED AND IT WAS CANCELED TO USE. A TSUNAMI STENT FAILED TO CROSS TO THE LESION, TOO." FOLLOW UP INFO REC'D INDICATED THAT THE S670 STENT HAD BEEN PLACED APPROX 3 YRS PRIOR TO THIS PROCEDURE AND HAD RESTENOSED. THE EXPRESS2 MONORAIL CORONARY STENT WAS PULLED BACK THROUGH THE GUIDE CATHETER. THE STENT DAMAGE WAS NOTED AT DEVICE REMOVAL. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER EVENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC 8MM X 2.5 MM 6355131

    Patients

    Seq Age Sex Outcome Treatment
    1 *