BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLRFLXC

    MDR report key: 1901017 · Received November 17, 2010

    Report

    Report Number
    2648035-2010-00221
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR ANALYSIS BY THE MANUFACTURER AND IS CURRENTLY BEING EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND MEASURED FOR DIOPTER. THE RESULTS WERE CONSISTENT WITH THE LABELED DIOPTER OF 21.50. ALL OTHER OPTICAL MEASUREMENTS MET MANUFACTURING SPECIFICATIONS. THESE RESULTS REASONABLY SUGGEST THIS ISSUE IS NOT MANUFACTURING RELATED. WE WILL CONTINUE TO MONITOR AND TREND ALL REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON TEAR OCCURRED. THE PATIENT PRESENTED IN CRITICAL CONDITION WITH AN ACUTE MYOCARDIAL INFARCTION. THE VERY TORTUOUS AND CALCIFIED LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE MAVERICK2 MONORAL 2.5 X 20MM BALLOON WAS ADVANCED FOR PREDILATION OF THE LESION, HOWEVER THE BALLOON DID NOT EXPAND. THE PHYSICIAN REMOVED THE BALLOON FROM THE PATIENT WITHOUT DIFFICULTY AND IT WAS NOTED THAT THERE WAS A TEAR OF THE BALLOON MATERIAL. THE PROCEDURE WAS THEN COMPLETED WITH PREDILATION WITH A 2.5 X 20MM NON-BSC BALLOON AND 3 NON-BSC STENTS WERE DEPLOYED IN THE LAD AND LEFT CIRCUMFLEX. DURING IMPLANTATION OF THE STENTS, THE PATIENT'S CONDITION WORSENED AND THE PATIENT WENT INTO SHOCK. THE PATIENT WAS TRANSFERRED TO THE ICU POST-PROCEDURE AND PASSED AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 1 MONTH AFTER THE INITIAL IMPLANT. THE CAUSE OF THE IOL EXPLANT WAS THE PATIENT'S POST OPERATIVE RESULT OF 6 DIOPTERS OF ASTIGMATISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLRFLXC MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS CLRFLXC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention