BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3062665 · Received April 17, 2013

    Report

    Report Number
    9612164-2013-00431
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    November 11, 2012
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-STENT EMBOLIZATION (DISLODGEMENT) IS LISTED IN THE PRODUCT IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF CORONARY STENTING DEVICES. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO PATIENT VESSEL MORPHOLOGY. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT EMBOLIZATION (DISLODGEMENT) IS LISTED IN THE PRODUCT IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF CORONARY STENTING DEVICES. 50 DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO PATIENT VESSEL MORPHOLOGY. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT TO THE LEFT CIRCUMFLEX, LEFT MAIN. IN TRYING TO DELIVER THE STENT AROUND THE ANGLE OF THE LEFT MAIN, LEFT CIRCUMFLEX, THE STENT BECAME ENTRAPPED, AND SUBSEQUENTLY DISLODGED FROM THE BALLOON. UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE WITH MULTIPLE SNARES - A 2MM AND A 4MM SNARE, BUT COULD NOT RETRIEVE THE STENT. EVALUATION SUMMARY : THE DISTAL TIP WAS SLIGHTLY FLARED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. INITIAL MANDREL MOVEMENT FAILED DUE TO A BLOCKAGE IN THE INNER LUMEN. THE BLOCKAGE COULD NOT BE REMOVED, HOWEVER, IS MOST LIKELY DUE TO CRYSTALLIZED SALINE/BLOOD FOLLOWING FLUSHING OF THE GUIDE WIRE LUMEN PRIOR TO THE PROCEDURE, LOADING ON TO THE GUIDE WIRE AND INSERTION. THE STENT WAS NOT PRESENT ON THE BALLOON. CRIMP IMPRESSIONS WERE EVIDENT ALONG THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165054 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006122057

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention