BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY SET

    MDR report key: 2500861 · Received March 16, 2012

    Report

    Report Number
    2183460-2012-00003
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    February 15, 2012
    Report Date
    March 16, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF PATIENT EXPERIENCING HYPOTENSION AND BRADYCARDIA DURING ANGIOJET THERAPY. THE PATIENT IS A (B)(6) FEMALE WITH A HISTORY OF END STAGE RENAL DISEASE REQUIRING DIALYSIS, DIABETES MELLITUS, HYPERTENSION, CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE REQUIRING HOME OXYGEN AND RECENT RIGHT LEG AMPUTATION. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM FOR A LEFT UPPER ARM DECLOT PROCEDURE. ANESTHESIA WAS MONITORED WITH CARE. AN ANGIOJET ULTRA AVX THROMBECTOMY SET WAS ADVANCED THROUGH THE GRAFT AND USED FOR THROMBECTOMY. AFTER ANGIOJET THERAPY, AN 8X80 MILLIMETER VENOUS ANGIOPLASTY BALLOON WAS INSERTED THROUGH THE ANTEGRADE SHEATH AND USED TO MACERATE THE CLOTS AND IDENTIFY RESIDUAL STENOSIS. SEVERAL STENOSES OF 60-70 PERCENT WERE NOTED WITHIN THE AV GRAFT CONDUIT AS WELL AS THE VENOUS AND OUTFLOW STENT. THE ARTERIAL PLUG WAS REMOVED. DURING THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC. THIS WAS FELT TO BE THE RESPIRATORY DISTRESS DUE TO SEDATION. IN ADDITION, THE PHYSICIAN THOUGHT THE ANGIOJET DEVICE WAS A CONTRIBUTING FACTOR TO THE HYPOTENSIVE AND BRADYCARDIAC EVENT. THE PATIENT DID REQUIRE INTUBATION AND ADMISSION TO THE INTENSIVE CARE UNIT. THE ANGIOJET ULTRA AVX THROMBECTOMY SET INSTRUCTIONS FOR USE WARNS THE USER ABOUT ARRHYTHMIAS AS SHOWN BELOW. "CARDIAC ARRHYTHMIAS DURING CATHETER OPERATION HAVE BEEN REPORTED IN A SMALL NUMBER OF PATIENTS. CARDIAC RHYTHM SHOULD BE MONITORED DURING CATHETER USE AND APPROPRIATE MANAGEMENT, SUCH AS TEMPORARY PACING, BE EMPLOYED, IF NEEDED." THE ANGIOJET ULTRA AVX THROMBECTOMY SET INSTRUCTIONS FOR USE ALSO LISTS HYPOTENSION/HYPERTENSION AS A POTENTIAL ADVERSE EVENT. SINCE THE PATIENT REQUIRED INTERVENTION TO TREAT THE HYPOTENSION AND BRADYCARDIA EVENT AND THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND THE NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT. THIS EVENT IS CONSIDERED REPORTABLE.

    Description of Event or Problem · 1

    PATIENT HISTORY (TAKEN FROM CONSULT NOTE) - END STAGE RENAL DISEASE REQUIRING DIALYSIS, DIABETES MELLITUS, HYPERTENSION, CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE REQUIRING HOME OXYGEN. RECENTLY HAD RIGHT LEG AMPUTATED. DECLOT PROCEDURE (TAKEN FROM OPERATIVE NOTE) - PATIENT BROUGHT TO THE OPERATING ROOM FOR LEFT UPPER ARM DECLOT. MONITORED ANESTHESIA CARE WAS GIVEN. AN ANGIOJET THROMBECTOMY DEVICE IS ADVANCED THROUGH THE GRAFT AND USED TO DISSOLVE AND ASPIRATE THROMBUS. NEXT, AN 8X80 MILLIMETERS VENOUS ANGIOPLASTY BALLOON WAS INSERTED THROUGH THE ANTEGRADE SHEATH AND USED TO MACERATE THE CLOTS AND IDENTIFY STENOSES. SEVERAL STENOSES OF 60-70 PERCENT ARE NOTED WITHIN THE AV GRAFT CONDUIT AS WELL AS THE VENOUS AND OUTFLOW STENT. THE ARTERIAL PLUG WAS REMOVED. DURING THE CASE, THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC. THIS WAS FELT TO BE RESPIRATORY DISTRESS DUE TO SEDATION. THE PATIENT DID REQUIRE INTUBATION AND ADMISSION TO THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY SET THROMBECTOMY SET DXE BAYER INTERVENTIONAL, INC 105039-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention