BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 1849068 · Received September 23, 2010

    Report

    Report Number
    2183460-2010-00008
    Event Type
    Other
    Date Received
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL/POSSIS
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONSISTS OF A PATIENT REQUIRING DIALYSIS TO TREAT ACUTE RENAL FAILURE POST ANGIOJET THERAPY. NOTE: MEDRAD WAS INFORMED OF THIS EVENT AS A RESULT OF A PHYSICIAN PRESENTATION TO MEDRAD EMPLOYEES. THE PATIENT IS A (B)(6), FEMALE, WITH A HISTORY OF AORTOBIFEMORAL BYPASS (ABF), RIGHT TO LEFT FEM-FEM BYPASS, CORONARY ARTERY DISEASE (CAD), BREAST CANCER, HYPERTENSION, GASTRITIS, AND ESOPHAGITIS. IN ADDITION, THE PATIENT QUIT SMOKING 8 YEARS PRIOR. THE PATIENT'S SERUM CREATININE (SCR) WAS 0.9 MG/DL PRIOR TO PROCEDURE. THE PATIENT PRESENTED TO THE CATHLAB FOR REVASCULARIZATION OF THE LEFT LEG BYPASS GRAFT WHICH WAS OCCLUDED. AT A 7 MONTH FOLLOW-UP VISIT POST THE INDEX PROCEDURE THE PATIENT STATED SHE HAD A 2 WEEK HISTORY OF WORSENING LEG PAIN BOTH WITH WALKING AND AT REST. THE PATIENT HAD AN MRI OF THE SPINE WHICH WAS NEGATIVE FOR DISK INJURY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANTICOAGULATION, ANTERIOR-GRAPHY, AND INTERVENTION TO TREAT OCCLUSIONS OF THE RIGHT TO LEFT FEM-FEM GRAFT AND RIGHT ARTERIAL FEMORAL GRAFT. THE PROCEDURE CONSISTED OF BALLOON ANGIOPLASTY, MECHANICAL THROMBECTOMY WITH THE ANGIOJET ULTRA AVX THROMBECTOMY SET, AND STENTING X1. THE PHYSICIAN STATED THAT RUN TIME FOR THE ANGIOJET DEVICE WAS APPROXIMATELY 10 MINUTES. A TOTAL OF 250 CC CONTRAST WAS USED. ANGIOGRAPHY SHOWED PATENCY IN ALL GRAFTS POST TREATMENT. FOLLOWING THE PROCEDURE THE PATIENT DEVELOPED CHEST PAIN, HEMATURIA, GI BLEED, RENAL FAILURE, AND ANURIA. IT WAS ASSUMED THAT THE BLEEDING WAS SECONDARY TO HEPARIN/INTEGRILIN WHICH WAS GIVEN FOR THE MYOCARDIAL INFARCTION (MI). THE PATIENT IMPROVED OVER 24 HOURS AFTER STOPPING INTEGRILIN. THE PATIENTS SCR WAS 2.6MG/DL 24 HOURS POST PROCEDURE AND 4.2 MG/DL 48 HOURS POST PROCEDURE. THE PATIENT WAS STARTED ON DIALYSIS FOR VOLUME CONTROL AS WELL AS ION POTASSIUM (K+). ON DAY 16 POST PROCEDURE THE PATIENT'S SCR WAS 3.7 MG/DL. EIGHT WEEKS LATER THE PATIENT'S SCR RETURNED TO 1.2 MG/DL. THE PATIENT WAS ASYMPTOMATIC WITH HER LEGS BUT WAS STILL RECOVERING FROM HOSPITALIZATION. IN A POST PRESENTATION CONVERSATION WITH THE PHYSICIAN, THE PHYSICIAN WAS AWARE OF THE RECOMMENDED RUN TIME FOR THE ANGIOJET DEVICES BUT WAS UNAWARE OF THE PATIENT HYDRATION RECOMMENDATIONS IN THE PRODUCT INFORMATION FOR USE (IFU). THE PHYSICIAN STATED HE HAD NOT READ THE PRODUCT IFU. THE ANGIOJET PERIPHERAL ARTERIAL AND VENOUS IFU STATES THE FOLLOWING WARNINGS AND PRECAUTIONS: "LARGE THROMBUS BURDENS IN PERIPHERAL VEINS AND OTHER VESSELS MAY RESULT IN SIGNIFICANT HEMOGLOBINEMIA WHICH SHOULD BE MONITORED TO MANAGE POSSIBLE RENAL, PANCREATIC OR OTHER ADVERSE EVENTS." "EVALUATE THE PATIENT'S RISK TOLERANCE FOR HEMOGLOBINEMIA AND RELATED SEQUELAE PRIOR TO THE PROCEDURE. CONSIDER HYDRATION PRIOR TO, DURING, AND AFTER THE PROCEDURE AS APPROPRIATE TO THE PATIENT'S OVERALL MEDICAL CONDITION." THIS EVENT IS CONSIDERED REPORTABLE AS INTERVENTION (DIALYSIS) WAS REQUIRED DUE TO INCREASED SCR LEVEL WHICH RESULTED IN ACUTE RENAL FAILURE.

    Description of Event or Problem · 1

    DR. (B)(6) DESCRIBED THIS CASE AS ACUTE RENAL INJURY REQUIRING SHORT TERM DIALYSIS. THE PATIENT PRESENTED WITH ELEVATED CREATININE LEVELS, BUT NEEDED LEG REVASCULARIZATION. HE USED ANGIOJET IN COMBINATION WITH X-RAY CONTRAST. HE USED AN AVX CATHETER AND RUN TIMES WERE ABOUT 10 MINUTES. THE PT. EXPERIENCED SOME HEMATURIA. THE PT. HAD AN INCREASE IN CREATINE LEVELS, SO THE DECISION WAS MADE TO SEND THE PT TO DIALYSIS. THE DIALYSIS WAS A SHORT TERM MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE MEDRAD INTERVENTIONAL/POSSIS 105039-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention