BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1970078 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00113
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 17, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (BASED ON THE LIMITED INFORMATION PROVIDED, THE STENT WAS DAMAGED DURING THE PROCEDURE), (STENT DEFORMATION). CONCLUSIONS: (BASED ON THE LIMITED INFORMATION PROVIDED, THE STENT DAMAGE WAS DAMAGED DURING THE PROCEDURE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO ADVANCE A 2.5MM DIAMETER X 30MM LENGTH ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT TO A TARGET LESION AND DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT WAS DAMAGED. THERE WAS NO REPORTED INTERVENTION OR PT INJURY. NO OTHER CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE ERES25030X IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT ENSP25030X.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK