BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2103000 · Received May 5, 2011

    Report

    Report Number
    9612164-2011-00377
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: (THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED BASED ON THE INFO PROVIDED); (STENT DISLODGEMENT).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.75 MM DIAMETER X 26 MM LENGTH INTEGRITY RX BARE METAL STENT INTO THE RIGHT CORONARY ARTERY OF A PT. DURING PLACEMENT OF THE STENT IN THE RCA, THE STENT WAS NOTED TO BE ADVANCING AHEAD OF THE BALLOON. THE STENT WAS THOUGHT TO HAVE BECOME DISLODGED FROM THE BALLOON. A SMALLER BALLOON WAS PLACED IN THE PT AND THAT BALLOON WAS INFLATED TO TRAP THE DISLODGED STENT. ANOTHER STENT WAS PLACED WITHOUT COMPLICATION. NO OTHER CLINICAL SEQUELAE WERE REPORTED. REFERENCE USER REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0004689611

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention