BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 1943928 · Received December 1, 2010

    Report

    Report Number
    2953200-2010-02357
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (SEVERE TORTUOSITY, STENOSIS), (NUMEROUS FAILED ATTEMPTS TO DELIVER THE STENT ACROSS THE TORTUOUS LESION), (STENT DEFORMATION, FAILURE TO DELIVER THE STENT). EVAL, CONCLUSIONS: (SEVERE TORTUOSITY, STENOSIS), (NUMEROUS FAILED ATTEMPTS TO DELIVER THE STENT ACROSS THE TORTUOUS LESION). DEVICE EVAL: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPEC. A NUMBER OF STRUTS ON THE 5TH AND 6TH DISTAL STENT SEGMENTS WERE RAISED DEFORMED AND PULLED DISTALLY. NO FURTHER DAMAGE NOTED. CINE IMAGE EVAL: THE IMAGES CONFIRMED THAT LESION WAS LOCATED IN A MARGINAL LCX AND HAD EXCESSIVE TORTUOSITY. THE IMAGES SHOW THAT THE DEVICE WAS ADVANCED TOWARDS THE LESION FOLLOWING TWO PRE-DILATION ATTEMPTS. THERE APPEARS TO BE AN IMAGE OF AN ATTEMPTED STENT DELIVERY WITH A SUPPORT WIRE WHICH IS MOST LIKELY THE RESOLUTE INTEGRITY STENT. THE CD IMAGES SHOW ADD'L PRE-DILATIONS AND THE USE OF A MINI GUIDE CATHETER TO ASSIST THE EVENTUAL SUCCESSFUL DEPLOYMENT OF ANOTHER STENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5 MM DIAMETER X 12 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT TO A LESION IN THE MARGINAL LCX. THE TARGET LESION EXHIBITED 98% STENOSIS, EXCESSIVE TORTUOSITY AND SOME CALCIFICATION. THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT AROUND THE EXCESSIVE BENDS OF THE LESION. A SECOND ATTEMPT WAS MADE TO ADVANCE THE STENT USING A STRONGER EXTRA SUPPORT WIRE, BUT THIS ATTEMPT WAS ALSO UNSUCCESSFUL. THE DEVICE WAS REMOVED FROM THE PT. FOLLOWING THIS ATTEMPT THE PHYSICIAN NOTED THAT SOME OF THE STENT STRUTS HAD BECOME DAMAGED WHILE ATTEMPTING TO CROSS THE TORTUOUS LESION. NO HEALTH HAZARD WAS CAUSED TO THE PT AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0004183332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK