BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1230350 · Received November 7, 2008

    Report

    Report Number
    2953200-2008-01022
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE CATHETER SHAFT WAS BROKEN IN TWO AND SEVERELY TWISTED. THE PROXIMAL PART OF THE SHAFT MEASURED APPROX 16CM FROM THE DISTAL END OF THE STRAIN RELIEF AND WAS BENT. THE DISTAL PART OF THE SHAFT WAS ALSO KINKED IN SEVERAL PLACES. THE STENT WAS ON THE BALLOON AS PER SPECIFICATION WITH SLIGHT BLOOD RESIDUE NOTED UNDER THE BALLOON FOLDS. INITIAL MANDREL MOVEMENT FAILED DUE TO A BLOCKAGE IN THE INNER LUMEN. THE STENT WAS POSITIONED BETWEEN THE BALLOON PILLOWS ON THE UN-INFLATED BALLOON. THE PROXIMAL SHAFT HAD DETACHED 16CM DISTAL TO THE STRAIN RELIEF. THE SHAFT WAS BENT AT THE BREAK SITE. BOTH ENDS OF THE SHAFT AT THE BREAK SITE WERE OVAL IN SHAPE SUGGESTING THAT THE SHAFT HAD BEEN KINKED PRIOR TO THE SHAFT BREAKING. RECREATION STUDIES COMPLETED BY R&D SHOW THAT KINKING AND SUBSEQUENT RE-STRAIGHTENING OF THE SHAFT CAN RESULT IN A SHAFT BREAK, BREAKAGES CAN ALSO OCCUR IF PRODUCT IS EXPOSED TO BENDING FORCE DURING DELIVERY. ALTHOUGH INFO FROM THE FIELD CONFIRMED THAT THE DEVICE WAS NOT KINKED, THE NATURE OF THE BREAK WAS CONSISTENT WITH BREAKAGES NOTED IN THE RECREATION STUDIES. INFO RECEIVED FROM THE ACCOUNT CONFIRMED THAT THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 18 MM LENGTH DRIVER RX CORONARY STENT SYSTEM WAS INSERTED INTO PT FOR THE TREATMENT OF A CIRCUMFLEX LESION. THE VESSEL MORPHOLOGY WAS REPORTED TO BE NON-TORTUOUS WITH NO CALCIFICATION AND 80% STENOSIS. IT IS UNK IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REACH THE LESION WITH THE DRIVER DELIVERY SYSTEM; HOWEVER WAS UNABLE TO CROSS THE LESION. DURING HIS ATTEMPT THE SHAFT OF THE DELIVERY SYSTEM BROKE. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. ANOTHER DRIVER STENT WAS DEPLOYED AT THE LESION SITE TO COMPLETE THE CASE. THE PT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000575803

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK