BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLENT PROXI THROMBECTOMY SET

    MDR report key: 4176278 · Received October 14, 2014

    Report

    Report Number
    2183460-2014-00018
    Event Type
    Death
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOJET SOLENT PROXI CATHETER THAT WAS USED DURING THE NOTED EVENT WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. THE CUSTOMER DECLINED A SERVICE CHECK OF THE ANGIOJET ULTRA CONSOLE. THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS THE ASSOCATION BETWEEN THE ANGIOJET DEVICE AND NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    EVENT CONSISTS OF A PT DEATH POST ANGIOJET PROCEDURE. A PT WAS ADMITTED TO THE HOSPITAL AFTER SUSTAINING A GUNSHOT WOUND TO THE RIGHT LEG, WHICH INJURED THE FEMORAL ARTERY AND VEIN. SURGERY WAS PERFORMED TO REPAIR THE WOUND. WITHIN ONE WEEK AFTER SURGERY, THE PT WAS DIAGNOSED WITH A RIGHT POPLITEAL AND CALF DEEP VEIN THROMBOSIS AND UNDERWENT A FASCIOTOMY OF THE RIGHT LEG DUE TO TENSE SWELLING. BETWEEN THE ADMISSION AND THE PLANNED DISCHARGE, 11 DAYS AFTER THE INITIAL EVENT, THE PT RECEIVED ANTICOAGULANTS TO PREVENT BLOOD CLOT FORMING. WITHIN A FEW DAYS AFTER BEING RE-ADMITTED TO THE HOSPITAL, THE PT WAS DIAGNOSED WITH RENAL FAILURE; HENCE, DIALYSIS WAS INITIATED. THE PT WAS ALSO DIAGNOSED WITH EXTENSIVE BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSES. FASCIOTOMY WAS PERFORMED ON THE LEFT LEG TO RELIEVE THE PHLEGMASIA, AN ACUTE PROCESS THAT BEGINS WITH A DEEP VEIN THROMBOSIS THAT PROGRESSES TO TOTAL OCCLUSION OF THE DEEP VENOUS SYSTEM IF NOT TREATED. ONE WEEK LATER, FOLLOWING ANOTHER DOSE OF ANTICOAGULANT, THE DUPLEX PULSE SIGNALS WERE LOST IN BOTH LEGS SO THE PHYSICIAN DECIDED TO TREAT THE DVT IMMEDIATELY WITH ANGIOJET RAPID LYSIS USING A SOLENT PROXI CATHETER. TWO TREATMENTS WITH TPA (TISSUE PLASMINOGEN ACTIVATOR) AS WELL AS PLACEMENT OF A CDT (CATHETER DIRECTED THROMBOLYTIC) WERE PERFORMED. AS THE PT WAS BEING MOVED ONTO THE TRANSPORT TABLE, HE BECAME APHASIC AND BLEEDING FROM THE NOSE WAS OBSERVED. A CT SCAN IDENTIFIED A CEREBRAL HEMORRHAGE. THE PT THEN UNDERWENT A CRANIOTOMY TO RELIEVE THE PRESSURE ON THE BRAIN. FOUR DAYS LATER, THE PT DIED AS A RESULT OF BRAIN DEATH. AS PER THE INFO THAT WAS PROVIDED BY THE CUSTOMER, THE ANGIOJET WAS USED IN THE MANNER THAT IT WAS DESIGNED FOR AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650411 SOLENT PROXI THROMBECTOMY SET THROMBECTOMY CATHETER DXE BAYER INTERVENTIONAL 109676-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death