BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3951769 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00981
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 5, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (THE LESION HAD SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS). DEFORMATION PROBLEM EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (THE LESION HAD SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY AN ENDEAVOR RESOLUTE DRUG ELUTING STENT. THE TARGET LESION WAS IN THE MID RCA. THE LESION HAD SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS. THE LESION WAS PRE-DILATED TWICE WITH A 2.5X20MM AND 3.0X15MM BALLOON. THE STENT WAS UNABLE TO CROSS. IT WAS ALSO REPORTED THAT THE STENT WAS DAMAGED. THE PHYSICIAN BELIEVES THAT THE DIFFICULTY EXPERIENCED WAS DUE TO THE LESION MORPHOLOGY. THE PHYSICIAN STATED ¿THE ARTERY HAD A VERY TORTUOUS STRUCTURE SO THE STENT COULD NOT PASS THROUGH THE LESION.¿ NO INTERVENTIONS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATION: THE DISTAL TIP WAS FLARED AND SLIGHTLY FLATTENED. A NUMBER OF STRUTS ON THE 18TH AND 19TH PROXIMAL STENT SEGMENTS WERE RAISED AND DEFORMED. THE 23RD AND 24TH PROXIMAL SEGMENTS WERE DEFORMED. THE REMAINING SEGMENTS WERE INTACT. THERE WAS NO FURTHER DAMAGE EVIDENT TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430591 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006858278

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR