BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLENT OMNI THROMBECTOMY SET

    MDR report key: 2687146 · Received August 3, 2012

    Report

    Report Number
    2183460-2012-00013
    Event Type
    Death
    Date Received
    August 3, 2012
    Report Date
    August 3, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A PT DEATH POST ANGIOJET PROCEDURE. THE PT IS AN (B)(6) MALE WITH A BILATERAL DEEP VEIN THROMBOSIS (DVT), PREVIOUSLY PLACED INFERIOR VENA CAVA (IVC) FILTER, AND RECENT HISTORY OF PULMONARY EMBOLISM (PE). THE PHYSICIAN ACCESSED THE LEFT POPLITEAL VEIN USING ULTRASOUND GUIDED TECHNIQUE. THE PHYSICIAN DELIVERED APPROX 40CC OF SALINE VIA ANGIOJET SOLENT OMNI POWER PULSE MODE AND THEN PERFORMED THROMBECTOMY WITH THE ANGIOJET SOLENT OMNI DEVICE WITH A RUN TIME OF 3:30 MINS IN THE LEFT VENOUS SYSTEM. AFTER THROMBECTOMY THE PHYSICIAN DELIVERED CONTRAST AND SAW THAT A CHANNEL HAD BEEN CREATED RESTORING BLOOD FLOW. THE PHYSICIAN THEN ACCESSED THE RIGHT POPLITEAL VEIN TO REMOVE THROMBUS FROM THE RIGHT VENOUS SYSTEM. AFTER USING POWER PULSE FOR APPROX 5 SECONDS THE PT STOPPED BREATHING. THE ANGIOJET SOLENT OMNI DEVICE WAS REMOVED FROM THE PT AND A CODE WAS CALLED. ANESTHESIA ARRIVED AND PERFORMED PROTOCOL STEPS FOR SEVERAL MINS. THE PHYSICIAN PLACED A 4FR DIAGNOSTIC CATHETER INTO THE PULMONARY ARTERY AND BREATHING WAS RESTORED. THE PT WAS TRANSFERRED TO THE CRITICAL CARE UNIT. A MEDRAD SALES REPRESENTATIVE WAS NOTIFIED ON (B)(6) 2012 THAT THE PT HAD DIED; HOWEVER, THE ACTUAL DATE OF THE PT'S DEATH WAS NOT GIVEN TO THE MEDRAD REPRESENTATIVE. THE IFU WARNS THE USER: "THE POTENTIAL FOR PULMONARY THROMBOEMBOLISM SHOULD BE CAREFULLY CONSIDERED WHEN THE THROMBECTOMY SETS ARE USED TO BREAK UP AND REMOVE PERIPHERAL VENOUS THROMBUS." "OPERATION OF THE CATHETER MAY CAUSE EMBOLIZATION OF SOME THROMBUS AND/OR THROMBOTIC PARTICULATE DEBRIS. DEBRIS EMBOLIZATION MAY CAUSE DISTAL VESSEL OCCLUSION, WHICH MAY FURTHER RESULT IN HYPOPERFUSION OR TISSUE NECROSIS." THE NUMBER OF DAYS POST ANGIOJET THROMBECTOMY WHEN THE PT DIED IS UNK. MEDRAD HAS CONTACTED THE HOSPITAL 4 TIMES WITHOUT SUCCESS IN GETTING THE DATA. THIS EVENT IS CONSIDERED REPORTABLE AS THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND THE NOTED EVENTS WHICH INCLUDE THE PE EPISODES AND THE NOTED PT'S DEATH CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    DR (B)(6) CALLED FOR CASE SUPPORT ON (B)(6) 2012. HE EXPLAINED AT THAT TIME THAT HE WAS PLANNING TO USE ANGIOJET TO TREAT A BILATERAL DVT IN AN (B)(6) MALE PT WITH IVC FILTER AND RECENT HISTORY OF PE. DR PLANNED ON USING ANGIOJET WHETHER WE WERE ABLE TO SUPPORT OR NOT. HE HAS USED ANGIOJET SEVERAL TIMES WITH AND WITHOUT OUR SUPPORT. HE FURTHER EXPLAINED THAT HE COULD NOT USE TPA WITH THIS PT AND PLANNED TO POWER PULSE WITH SALINE USING THE SOLENT OMNI CATHETER. DR ACCESSED THE LEFT POP VEIN USING ULTRASOUND GUIDED TECHNIQUE. HE DELIVERED APPROX 40CC OF SALINE DURING PP AND THEN DID 3:30MIN OF THROMBECTOMY. ONCE COMPLETED HE DELIVERED CONTRAST AND SAW THAT A CHANNEL HAD BEEN CREATED RESTORING BLOOD FLOW. DR THEN ACCESSED THE RIGHT POP VEIN TO REMOVE THROMBUS FROM THE RIGHT VENOUS SYSTEM. AFTER PP FOR ONLY 5 SEC (APPROX) THE PT STOPPED BREATHING. OMNI CATHETER WAS REMOVED FROM THE PP AND A CODE BLUE WAS CALLED. ANESTHESIA ARRIVED AND PERFORMED PROTOCOL STEPS FOR SEVERAL MINS. DR PLACED A 4FR DIAG CATHETER INTO THE PULMONARY ARTERY AND BREATHING WAS RESTORED. PT WAS THEN TRANSFERRED TO CRITICAL CARE UNIT. I WAS MADE AWARE OF THE PT DEATH ON (B)(6) 2012 VIA TEXT. ANY PT INFO THAT I AM AWARE OF IS IN THIS REPORT. THE PROCEDURE DATE WAS (B)(6) 2012. I DO NOT KNOW WHAT DAY THE PT DIED. THE PHYSICIAN SPOKE DIRECTLY WITH (B)(6) REGARDING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLENT OMNI THROMBECTOMY SET THROMBECTOMY SET DXE BAYER INTERVENTIONAL, INC 109681-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death