BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2022966 · Received February 24, 2011

    Report

    Report Number
    2953200-2011-00493
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 3, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: NO CONCLUSION CAN BE DRAWN. (USE OF FORCE TO ADVANCE THE STENT). (STENT DEFORMATION AND FAILURE TO CROSS THE LESION). CONCLUSION: (DEVICE WAS NOT IDENTIFIED AS THE ROOT CAUSE OF EVENT). (USE OF FORCE TO ADVANCE THE STENT). EVAL SUMMARY: THE DEVICE WAS BENT, WAVY AND KINKED APPROX 16CM DISTAL TO THE STRAIN RELIEF. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPEC. A NUMBER OF STRUTS ON THE 8TH DISTAL STENT SEGMENT WERE RAISED AND DEFORMED. THE 13TH DISTAL STENT SEGMENTS WERE SLIGHTLY RAISED. NO FURTHER DAMAGE NOTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5 MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT. THE ANGIOGRAPH SHOWED 40% STENOSIS IN THE BODY OF LM, A DIFFUSED LESION OF LAD, RCA AND LCX. USING A GUIDE WIRE, THE DISTAL OF LAD WAS DILATED USING A BALLOON. THE PHYSICIAN ATTEMPTED TO IMPLANT THE ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT THROUGH THE LESION BUT FAILED. RESISTANCE WAS NOTICED WHEN ADVANCING THE DEVICE TO THE TARGET REGION. THE PHYSICIAN USED ANOTHER STENT AND THE OPERATION WAS SUCCESSFUL. NO PT INJURY OCCURRED AND 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 0004541356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK