BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2001518 · Received January 26, 2011

    Report

    Report Number
    2953200-2011-00177
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 27, 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
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE LAST TWO PROXIMAL STENT SEGMENTS WERE POSITIONED ON THE BALLOON AS PER SPEC; THE REMAINING SEGMENTS WERE STRETCHED BEYOND THE DISTAL TIP AND DEFORMED. THE DISTAL AND MIDDLE STENT WAS STRETCHED AND SEVERELY DAMAGED. THE PROXIMAL FIRST AND SECOND STENT STRUTS WERE VISUALLY ACCEPTABLE. THE PROXIMAL PILLOW FOLDS WERE DISTURBED. (B)(4). EVAL, RESULTS: (DELIVERY OF UNDEPLOYED STENT THROUGH THE CELL OF A PREVIOUSLY DEPLOYED STENT). (ENDEAVOR SPRINT STENT CAUGHT ON PREVIOUSLY DEPLOYED STENT). (STENT DEFORMATION AND FAILURE TO DELIVER THE STENT). CONCLUSIONS: (DELIVERY OF UNDEPLOYED STENT THROUGH THE CELL OF A PREVIOUSLY DEPLOYED STENT). (ENDEAVOR SPRINT STENT CAUGHT ON PREVIOUSLY DEPLOYED STENT).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA. THE TARGET LESION EXHIBITED 70% STENOSIS AND SOME CALCIFICATION. THE PHYSICIAN HAD PREVIOUSLY SUCCESSFULLY IMPLANTED AN ENDEAVOR SPRINT STENT TO ANOTHER VESSEL. AN ATTEMPT WAS THEN MADE TO IMPLANT THE RELEVANT ENDEAVOR SPRINT STENT, HOWEVER, THE PHYSICIAN EXPERIENCED DIFFICULTIES PASSING THE UNDEPLOYED ENDEAVOR SPRINT THROUGH THE PREVIOUSLY DEPLOYED STENT AND REMOVED THE DEVICE FROM THE PT. UPON REMOVAL, IT WAS NOTED THAT THE STRUTS OF THE STENT WERE DAMAGED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TARGET LESION WAS TREATED USING ANOTHER ENDEAVOR SPRINT STENT OF THE SAME SIZE. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0003388108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK