BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION

    MDR report key: 3202310 · Received June 5, 2013

    Report

    Report Number
    3008867907-2013-00004
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    May 30, 2013
    Manufacturer
    PLUROMED INC.
    Product Code
    OBC
    PMA / PMN Number
    P110003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    VENTRICULAR FIBRILLATION [VENTILATOR FIBRILLATION]. UNDISSOLVED LEGOO REMAINING IN VESSEL [PRODUCT SOLUBILITY ABNORMAL]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT RECEIVED LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION, DOSAGE REGIMEN NOT PROVIDED, DURING OFF-PUMP CABG (CORONARY ARTERY BYPASS GRAFTING). THE LOT NUMBER FOR LEGOO WAS NOT PROVIDED. IT WAS REPORTED THAT LEGOO WAS USED TO OCCLUDE 3 VESSELS AND WAS DISSOLVED USING COLD SALINE SUCCESSFULLY EACH TIME. THE SAME DAY (ON AN UNK DATE), THE PT EXPERIENCED THE LIFE-THREATENING EVENT OF VENTRICULAR FIBRILLATION AT THE END OF THE OFF PUMP CABG (CORONARY ARTERY BYPASS GRAFTING) CASE. IT WAS REPORTED BY THE PHYSICIAN THAT THERE COULD HAVE BEEN A POSSIBILITY OF AN AIR EMBOLISM CAUSING VENTRICULAR FIBRILLATION DUE TO SOME UNDISSOLVED LEGOO REMAINING IN THE VESSEL (PRODUCT DISSOLUTION ABNORMAL) WHICH CAUSED AN AIR POCKET WHEN IT DISSOLVED AFTER THE ANASTOMOSIS WAS COMPLETE. ON AN UNSPECIFIED DATE, THE EVENT OF VENTRICULAR FIBRILLATION RESOLVED. THE OUTCOME FOR THE EVENT OF "UNDISSOLVED LEGOO REMAINING IN THE VESSEL WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF VENTRICULAR FIBRILLATION WAS SEVERE. THE INTENSITY FOR THE EVENT OF "UNDISSOLVED LEGOO REMAINING IN THE VESSEL" WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN LEGOO AND THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249699 LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION ENDOVASCULAR OCCLUSION GEL OBC PLUROMED INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening