BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 1901593 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02231
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (INCORRECT GUIDEWIRE LOADING TECHNIQUE). EVAL SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. THE BALLOON HAD BEEN PARTIALLY INFLATED. BLOOD AND CONTRAST WERE EVIDENT IN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS PLACED IN WATER BATH TO SOFTEN THE BLOOD AND CONTRAST IN ORDER TO PERFORM NEGATIVE PREP. NEGATIVE PREP COULD STILL NOT BE PERFORMED, SO THE DEVICE WAS CUT DISTAL TO THE GUIDEWIRE ENTRY PORT. THE BALLOON WAS INFLATED TO 9ATMS AND 16ATMS. A SMALL AMOUNT OF LIQUID EXITED THE DISTAL TIP INDICATING AN INNER LUMEN LEAK. THE INNER WAS REMOVED FROM THE OUTER LUMEN AND A HOLE WAS CONFIRMED APPROX 5MM PROXIMAL TO THE PROXIMAL MARKER BAND. THE PUNCTURED MATERIAL ON THE INNER WAS PROTRUDING OUTWARDS AND MOVED IN A DISTAL TO PROXIMAL DIRECTION SUGGESTING THAT THE DAMAGE OCCURRED DURING GUIDEWIRE LOADING ATTEMPTS. A CD OF PROCEDURAL IMAGES WAS ALSO PROVIDED FOR EVAL. THE CD IMAGES CONFIRMED THE DIFFICULT/DISEASED NATURE OF THE LESION. CD IMAGES OF THE DEVICE INFLATION SHOW CONTRAST PRESENT IN THE VESSEL DISTAL TO THE DEVICE, INDICATING THAT THE CONTRAST FLOWED OUT THROUGH THE DISTAL TIP AS EXPECTED FOR INNER LUMEN LEAKS.

    Description of Event or Problem · 1

    AN INTEGRITY RX CORONARY STENT SYSTEM, LENGTH 12MM, DIAMETER 3.0MM, WAS INTENDED TO TREAT A 100% STENOSED MID LAD LESION IN A PT. IT WAS REPORTED THAT THE BALLOON WAS NOTED TO HAVE BURST AT 10ATM. IT WAS REPORTED THAT MULTIPLE GUIDE CATHETER EXCHANGES WERE PERFORMED IN ORDER TO GAIN ADEQUATE SUPPORT. THE PROXIMAL VESSEL WAS PRE-DILATED SEVERAL INFLATIONS AND A 3 X 18MM INTEGRITY STENT WAS SUCCESSFULLY IMPLANTED. THE 3 X 18MM INTEGRITY WAS POST-DILATED AND THE MID LAD WAS BALLOONED. THE 3 X 12MM INTEGRITY WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NEGATIVE PREP WAS NOT PERFORMED PRIOR TO USE. THE 3X 12MM INTEGRITY WAS LOADED ONTO THE GUIDEWIRE AND ADVANCED TO THE LESION. IT WAS REPORTED THAT RESISTANCE WAS NOTED WHILE LOADING THE DEVICE ONTO THE WIRE AND WHEN TRYING TO CROSS STENOTIC LESION. ON INFLATION OF THE DEVICE AT THE LESION, THE BALLOON WAS NOTED TO HAVE BURST AT 10ATM DUE TO BLOOD FLASHBACK IN THE INDEFLATOR. FLUOROSCOPY WAS PERFORMED AND SHOWED THAT THE STENT WAS DISTAL TO THE STENOSIS, BUT THE BALLOON HAD MOVED BACK, PROXIMAL TO THE STENOSIS. ANOTHER BALLOON WAS INFLATED AT THE POSITION OF THE STENT AND CASE WAS ENDED. PT WAS TRANSFERRED TO CORONARY CARE UNIT WITH NO ADVERSE EVENT REPORTED AND NO ADD'L CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0003529677

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention