BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLENT OMNI THROMBECTOMY SET

    MDR report key: 3027994 · Received March 27, 2013

    Report

    Report Number
    2183460-2013-00002
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF PT DEATH POST ANGIOJET THERAPY. THE PT IS A (B)(6) MALE WITH AN AV-ACCESS GRAFT FOR DIALYSIS. THE PHYSICIAN ACHIEVED ARTERIAL ACCESS THROUGH THE RIGHT FEMORAL ARTERY. VENOUS ACCESS WAS GAINED THROUGH THE LEFT BRACHIAL VEIN. THE PHYSICIAN USED AN ANGIOJET SOLENT OMNI THROMBECTOMY SET TO TREAT THE AV-ACCESS GRAFT AS MORE CATHETER LENGTH WAS NEEDED. THE OMNI DEVICE WAS PRIMED WITH 15 CCS AND WAS THEN PLACED AND ACTIVATED FOR A TOTAL OF 196 CCS, RESULTING IN ESTABLISHED FLOW. AN ANGIOPLASTY BALLOON WAS BEING PREPPED WHEN THE ANESTHESIOLOGIST CALLED OUT ST SEGMENT ELEVATION AND A CODE WAS CALLED. THE PT WAS PRONOUNCED DEAD AN HOUR LATER. THE PHYSICIAN TOLD BAYER CLINICAL SPECIALIST THAT THE PT'S DEATH PROBABLY HAD NOTHING TO DO WITH THE THROMBECTOMY PROCEDURE AND THE DIALYSIS PTS ARE THE SICKEST PTS IN THE HOSPITAL. THE FACT THAT THERE WAS AN ST ELEVATION INDICATED THE PT HAD A MYOCARDIAL INFARCTION (MI). EVEN THOUGH THE PHYSICIAN STATED THAT THE ANGIOJET SOLENT OMNI DEVICE PROBABLY DID NOT CONTRIBUTE TO THE PTS DEATH, THE RELATIONSHIP BETWEEN THE OMNI DEVICE AND THE CAUSE OF PT DEATH HAS NOT BEEN CONCLUSIVELY RULED OUT AT THIS TIME. THIS EVENT IS DETERMINED TO BE A REPORTABLE EVENT SINCE THE RELATIONSHIP BETWEEN THE OMNI DEVICE AND THE PT DEATH IS INCONCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    ARTERIAL ACCESS WAS GAINED THROUGH THE RIGHT FEMORAL ARTERY. VENOUS ACCESS WAS GAINED THROUGH THE LEFT ARM BRACHIAL VEIN. OMNI THROMBECTOMY CATHETER WAS USED DUE TO NEEDING MORE CATHETER LENGTH. CATHETER WAS PRIMED FOR 15 CCS. CATHETER WAS PLACED AND ACTIVATED FOR A TOTAL OF 196 CCS. FLOW WAS ESTABLISHED AND AS THEY WERE GETTING AN ANGIOPLASTY BALLOON PREPPED, THE ANESTHESIOLOGIST CALLED OUT ST SEGMENT ELEVATION. I LEFT THE ROOM AS THEY CALLED A CODE. THEY PRONOUNCED THE PT AS EXPIRED ABOUT AN HOUR LATER. DR (B)(6) TOOK ME ASIDE AND TOLD ME THAT IT PROBABLY HAD NOTHING TO DO WITH THE THROMBECTOMY, THESE DIALYSIS PTS ARE THE SICKEST PTS IN THE HOSPITAL. THE FACT THAT THERE WAS ST ELEVATION WAS THAT THE PT HAD AN MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125685 SOLENT OMNI THROMBECTOMY SET THROMBECTOMY SET DXE BAYER INTERVENTIONAL 109681-001 136204

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death