BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1921204 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02479
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS/CONCLUSIONS: VERY CALCIFIED LESION, 100% STENOSIS. ATTEMPT TO RETRACT DEVICE BACK INTO THE GUIDE CATHETER. USE OF FORCE. RESULTS: STENT DEFORMATION, FAILURE TO DELIVER THE STENT. EVAL METHODS: FILM. CINE IMAGE EVAL: THE IMAGES CONFIRMED THE DISEASED, STENOTIC CONDITION OF THE VESSEL. THE PRE-DILATION OF THE LESION PRIOR TO THE ATTEMPTED DELIVERY OF THE ENDEAVOR RESOLUTE STENT CAN BE SEEN. THE IMAGES ALSO SHOW THE DEVICE PARTIALLY INSIDE THE GUIDE CATHETER DURING THE ATTEMPT TO REMOVE THE DEVICE. FURTHER IMAGES SHOW THE SUCCESSFUL DEPLOYMENT OF ANOTHER ENDEAVOR RESOLUTE STENT. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE US; HOWEVER IT IS SIMILAR TO THE US DISTRIBUTED PRODUCT EN27530X. DEVICE EVAL: THE DEVICE WAS RETURNED INSIDE THE GUIDE CATHETER WITH A GUIDE-WIRE ATTACHED. THE BALLOON AND TIP WERE EXPOSED BEYOND THE PROXIMAL EDGE OF THE GUIDE CATHETER. THE FIRST 3 DISTAL STENT SEGMENTS WERE INTACT AND POSITIONED ON THE BALLOON AS PER SPECIFICATIONS. THE REMAINING SEGMENTS WERE SEVERELY STRETCHED, DEFORMED AND PULLED DISTALLY EXPOSING THE PROXIMAL BALLOON PORTION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 30 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE PROXIMAL RCA. THE TARGET LESION WAS REPORTED TO BE VERY CALCIFIED WITH 100% STENOSIS. THE LESION WAS PRE-DILATED ONCE USING A 2.5 MM DIAMETER X 20 MM LENGTH SPRINTER LEGEND BALLOON UP TO 14 ATMS. FORCE WAS USED IN AN ATTEMPT TO CROSS THE STENT THROUGH THE STENOSIS, HOWEVER, THE DEVICE FAILED TO CROSS AND WAS REMOVED FROM THE PT. THE PHYSICIAN EXPERIENCED DIFFICULTIES RETRACTING THE STENT BACK INTO THE GUIDE CATHETER. UPON REMOVAL, THE STENT WAS NOTED TO BE DAMAGED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE TARGET LESION WAS SUCCESSFULLY TREATED USING ANOTHER ENDEAVOR RESOLUTE RX STENT OF THE SAME SIZE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002793888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK