BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2063859 · Received March 22, 2011

    Report

    Report Number
    9612164-2011-00097
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (VERY TORTUOUS LESION, 75% STENOSIS), (STENT EMBOLISM). EVAL, CONCLUSIONS: LACK OF EFFECTIVENESS RELATED TO PT CONDITION (VERY TORTUOUS LESION, 75% STENOSIS).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5 MM DIAMETER X 14 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A VERY TORTUOUS LESION IN THE CIRCUMFLEX WITH 75% STENOSIS. THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION, HOWEVER, THIS WAS NOT POSSIBLE SO THE TARGET LESION WAS PRE-DILATED USING A 2.5 MM X 12 MM SPRINTER LEGEND BALLOON. AN ATTEMPT WAS THEN MADE TO DELIVER THE ENDEAVOR SPRINT DEVICE. THE DISTAL END OF THE STENT WAS ABLE TO MAKE IT THROUGH THE OSTIUM, BUT THE PROXIMAL END COULD NOT MAKE THE TURN. THE PHYSICIAN REMOVED THE DEVICE AND REPLACED AN ADDITIONAL WIRE IN THE VESSEL. A SECOND ATTEMPT WAS MADE TO DELIVER THE ENDEAVOR SPRINT DEVICE, BUT THE STENT WOULD NOT PASS THE DISTAL LEFT MAIN ARTERY. THE DEVICE WAS REMOVED AND IT WAS OBSERVED THAT THE ENDEAVOR SPRINT STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO LOCATE THE DISLODGED STENT BUT COULD NOT. HOWEVER, THERE WERE NO VISIBLE SIGNS OF THE STENT IN THE PT'S BODY AFTER FLUOROSCOPY AND X-RAY WERE PERFORMED IN RADIOLOGY. THE PRESENCE OF THE ENDEAVOR SPRINT STENT HAD BEEN CONFIRMED ON THE STENT DELIVERY SYSTEM PRIOR TO INITIAL USE. THE TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THE PT IS REPORTED TO BE DOING WELL AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0003242656

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK