BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2875102 · Received December 17, 2012

    Report

    Report Number
    9612164-2012-01786
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: CAUSED BY ANOTHER DRUG/DEVICE (RESISTANCE WAS FELT IN THE AREA OF THE PREVIOUSLY DEPLOYED STENT AND THE DEVICE WAS UNABLE TO ADVANCE). FAILURE TO FOLLOW INSTRUCTIONS (FORCE USED IN AN ATTEMPT TO ADVANCE THE DEVICE). INHERENT RISK OF PROCEDURE (STENT EMBOLISM). EVALUATION CONCLUSIONS: ANOTHER DEVICE CAUSED FAILURE (RESISTANCE WAS FELT IN THE AREA OF THE PREVIOUSLY DEPLOYED STENT AND THE DEVICE WAS UNABLE TO ADVANCE). USER ERROR CONTRIBUTED TO EVENT (FORCE USED IN AN ATTEMPT TO ADVANCE THE DEVICE). KNOWN INHERENT RISK OF PROCEDURE (STENT EMBOLISM).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT THE DISTAL PL BRANCH OF THE RCA. AFTER THE POSITIONING OF THE GUIDING CATHETER AND THE GUIDE WIRE, THE PHYSICIAN TRIED TO ADVANCE THE RESOLUTE INTEGRITY STENT INTO THE PREVIOUSLY STENTED RIGHT CORONARY OSTIUM. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE TO THE TARGET LESION. THE DEVICE COULD NOT BE ADVANCED AND THE PHYSICIAN FELT A GREAT RESISTANCE WHILE PUSHING THE STENT. WHEN THE PHYSICIAN PULLED THE DELIVERY SYSTEM BACK THE STENT DISLODGED AND EMBOLIZED IN AORTA. BOTH LEFT AND RIGHT ARTERIES WERE CHECKED, HOWEVER THE DISLODGED STENT COULD NOT BE LOCATED. THE PROCEDURE WAS CONCLUDED WITH POBA OF THE DISTAL PORTION OF THE RIGHT CORONARY ARTERY, PERFORMED WITH TWO SEMI-COMPLIANT BALLOONS. THE STENT HAD BEEN INSPECTED AFTER REMOVAL OF THE PROTECTIVE SHEATH WITH NO ABNORMALITIES NOTED. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS GOOD AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005232443

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR