BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1940169 · Received December 23, 2010

    Report

    Report Number
    2953200-2010-02656
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: THE STENT WAS RETURNED. THE MID STENT SEGMENTS WERE SEVERELY ELONGATED AND THERE WERE NO WELD OR STENT STRUT MATERIAL BREAKAGES OR DETACHMENTS. RESULTS: (SEVERE CALCIFICATION OF LESION), (STENT DAMAGE AND FAILURE TO DELIVER THE STENT), (INTERACTION WITH THE Y-ADAPTOR), (FORCE USED). CONCLUSIONS: (SEVERE CALCIFICATION OF LESION), (USE OF FORCE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE LAD 6-7 FOLLOWING PRE-DILATATION. NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE DEVICE OR INSPECTION PRIOR TO USE. DELIVERY OF THE STENT WAS NOT SUCCESSFUL AND WHEN THE STENT WAS REMOVED, THE STENT STRUT WAS STRETCHED AND HALF OF THE STENT WAS DISPLACED ON THE BALLOON. ON REMOVAL OF THE DEVICE, THE DISPLACED STENT CAUGHT ON THE Y-ADAPTER RESULTING IN IT COMING OFF THE DEVICE IN-VITRO. AN ATTEMPT WAS MADE TO DELIVER A COMPETITOR STENT, BUT THIS WAS ALSO UNSUCCESSFUL. THE LESION WAS THEN PRE-DILATATED WITH A 3.5MM DIAMETER X 12MM LENGTH BALLOON AND THREE STENTS WERE DEPLOYED TO LAD 6-7. ALSO, S-STENT WAS DEPLOYED AT THE LEFT MAIN. BALLOONING AND STENTING ACTIVITIES SHOWED THAT THE TARGET LESIONS WERE RESISTANT TO BALLOON AND STENT INFLATION DUE TO THEIR SEVERELY DISEASED STATE. THE PROCEDURE WAS COMPLETED FOLLOWING REPEATED POST-DILATATIONS AND DIAGNOSIS WITH IVUS. NO HEALTH HAZARD WAS CAUSED TO THE PATIENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001666954

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK