BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION

    MDR report key: 3173445 · Received May 20, 2013

    Report

    Report Number
    3008867907-2013-00003
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 17, 2013
    Manufacturer
    PLUROMED INC
    Product Code
    OBC
    PMA / PMN Number
    P110003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF LEGOO IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    CLOT IN GRAFT PROXIMAL TO ANASTOMOSIS [GRAFT THROMBOSIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN VIA A SALES REP REGARDING A (B)(6) MALE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, LEGOO (ENDOVASCULAR OCCLUSION GEL) WAS INJECTED IN AN UNSPECIFIED VESSEL DURING A FEMORAL TIBIAL BYPASS SURGERY, FOR VASCULAR OCCLUSION. IT WAS REPORTED THAT THE PT HAD A CLOT FORMED IN GRAFT PROXIMAL TO ANASTOMOSIS. THE CLOT FORMED ABOUT 30 MINUTES AFTER USING LEGOO. THE COMPANY ASSESSED THE EVENT OF CLOT IN GRAFT PROXIMAL TO ANASTOMOSIS AS MEDICALLY SIGNIFICANT. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO FIX THE CLOT AND THE SURGERY PROCEEDED WITHOUT ANY FURTHER ISSUES. THE SAME DAY, THE PT RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF CLOT IN GRAFT PROXIMAL TO ANASTOMOSIS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP BETWEEN LEGOO AND THE EVENT OF CLOT IN GRAFT PROXIMAL TO ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223003 LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION ENDOVASCULAR OCCLUSION GEL OBC PLUROMED INC UNK 021413-05

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other