BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION

    MDR report key: 3204219 · Received June 14, 2013

    Report

    Report Number
    3008867907-2013-00005
    Event Type
    Other
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 10, 2013
    Manufacturer
    PLUROMED INC.
    Product Code
    OBC
    PMA / PMN Number
    P110003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONTINUED TO BLOCK THE VESSEL [VASCULAR OCCLUSION]. LEGOO PLUG MIGRATED DOWN THE VESSEL [PRODUCT SOLUBILITY ABNORMAL]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A SURGEON VIA A SALES REPRESENTATIVE REGARDING A PATIENT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, LEGOO (ENDOVASCULAR OCCLUSION GEL) WAS INJECTED (DOSAGE REGIMEN NOT PROVIDED) IN AN UNSPECIFIED VESSEL DURING A PERIPHERAL VASCULAR BYPASS SURGERY ON LEG, FOR VASCULAR OCCLUSION. THE LOT NUMBER FOR LEGOO WAS NOT PROVIDED. IT WAS REPORTED THAT "LEGOO PLUG MIGRATED DOWN THE VESSEL" AND "CONTINUED BLOCK THE VESSEL" EVEN AFTER ANASTOMOSIS WAS FINISHED BEING RECONNECTED. THE BLOCKAGE OCCURRED ON DISTAL SIDE OF ANASTOMOSIS. THE SURGEON DID FLUSH THE VESSEL WITH SALINE AFTER THE BYPASS AND CONFIRMED THE RECONNECTION, ALTHOUGH THE ULTRASOUND AFTER TIGHTENING DOWN THE VESSEL SHOWED SOMETHING IN THE VESSEL. THE SURGEON DID PULSE PROBE ON THE VESSEL AND DID NOT GET A PULSE ON 2 CM TO 3 CM OF THE VESSEL. FURTHER THE X-RAY WAS DONE WHICH ALSO CONFIRMED THAT SOMETHING WAS BLOCKING THE VESSEL. IT WAS REPORTED THAT THE SURGEON PULLED OUT SOMETHING WHICH WAS BLOCKING THE VESSEL. ACCORDING TO SALES REPRESENTATIVE, THE SURGEON PULLED OUT LEGOO FROM THE VESSEL. THE ULTRASOUND AND ANGIOGRAM WAS PERFORMED WHICH CONFIRMED THAT THE VESSEL WAS COMPLETELY OPEN. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON MIGHT HAVE USED THE INCORRECT TECHNIQUE TO DISSOLVE THE LEGOO PLUG. THE SURGEON PUSHED THE LEGOO PLUG DOWN THE VESSEL AND COLD SALINE NEVER GOT ALL THE WAY THROUGH THE LEGOO PLUG TO DISSOLVE IT ALL. IT WAS REPORTED THAT TRAINER WAS ALSO PRESENT DURING THE SURGERY. ON THE SAME DAY, THE PATIENT RECOVERED FROM THE EVENT OF "CONTINUED TO BLOCK THE VESSEL". THE OUTCOME OF THE EVENT OF "LEGOO PLUG MIGRATED DOWN THE VESSEL" WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN LEGOO AND BOTH THE EVENTS WAS NOT PROVIDED BY THE REPORTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272375 LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION ENDOVASCULAR OCCLUSION GEL OBC PLUROMED INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention