BEUDAMED
    FDA Adverse Event Other Summary report: N

    DVX THROMBECTOMY SET

    MDR report key: 2612700 · Received June 8, 2012

    Report

    Report Number
    2183460-2012-00008
    Event Type
    Other
    Date Received
    June 8, 2012
    Date of Event
    May 10, 2012
    Report Date
    June 7, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF PT EXPERIENCING HEMOLYSIS AND RENAL DYSFUNCTION POST ANGIO JET PROCEDURE. THE PT IS A (B)(6) MALE WITH UNK MEDICAL HISTORY. NOTE: THIS EVENT OCCURRED (B)(6). ON (B)(6) 2012, THE PT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT A SHORT INSTENT THROMBOSED LEFT ILIAC ARTERY WITH AN ANGIOJET ULTRA DVX THROMBECTOMY SET. FOLLOW THE PROCEDURE THE PT DEVELOPED HEMOLYSIS SYMPTOMS AND RENAL DYSFUNCTION. THE ANGIOJET PROCEDURE WAS A TECHNICAL SUCCESS WITHOUT ANY PROBLEMS DURING THE PROCEDURE. THE COMPLAINT REPORT STATED THE PT WAS IN THE INTENSIVE CARE UNIT. (ICU) POST PROCEDURE ON 1(B)(6) 2012. THE MEDRAD SALES REP VISITED THE HOSP AND WAS INFORMED THE PT'S CONDITION IMPROVED BUT WAS STILL CRITICAL. ON (B)(6) 2012, THE SALES REP VISITED THE HOSP AGAIN AND WAS INFORMED THAT THE PT WAS DOING VERY WELL AND WAS RELEASED FROM THE HOSP. THE SALES REP WAS NOT ABLE TO IDENTIFY WHAT TYPE OF INTERVENTION WAS PERFORMED TO TREAT THE HEMOLYSIS AND RENAL DYSFUNCTION EVENT. PRE-OPERATIVE CREATININE = 0.9 AND GFR = >60. POST-OPERATIVE CREATININE = 1.4 AND GFR = 52.3. THE ANGIO-JET RUN TIME WAS A TOTAL OF 180 SECONDS INCLUDING FLUSHING OF THE DEVICE. THE PT ALSO RECEIVED 185 ML OF SOLUTRAST 300 CONTRAST MEDIA. THE IFU WARNS THE USER: OPERATION OF THE ANGIOJET SYSTEM CAUSES TRANSIENT HEMOLYSIS WHICH MAY MANIFEST AS HEMOGLOBINURIA. TABLE 1 LISTS MAXIMUM RECOMMENDED RUN TIMES IN A FLOWING BLOOD FIELD AND TOTAL OPERATING TIME FOR EACH THROMBECTOMY SET. EVALUATE THE PT'S RISK TOLERANCE FOR HEMOGLOBINEMIA PRIOR TO THE PROCEDURE. CONSIDER HYDRATION PRIOR TO, DURING, AND AFTER THE PROCEDURE AS APPROPRIATE TO THE PT'S OVERALL MEDICAL CONDITION. 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." IN ADDITION, THE IFU ALSO WARNS THE USER OF THE FOLLOWING POTENTIAL ADVERSE EVENTS RELEVANT TO THIS EVENT: ACUTE RENAL FAILURE, PANCREATITIS, REACTIONS TO CONTRAST MEDIUM, HEMOLYSIS. SINCE THE PT REQUIRED AN UNSPECIFIED INTERVENTION AS A RESULT OF THE HEMOLYSIS AND RENAL DYSFUNCTION AND THE ASSOCIATION BETWEEN THE ANGIOJET DVX DEVICE AND THE NOTED EVENTS CANNOT BE CONCLUSIVELY RULED OUT THIS EVENT IS CONSIDERED A REPORTABLE EVENT IN THE U.S.

    Description of Event or Problem · 1

    THE PT (MALE (B)(6)) HAS DEVELOPED MASSIVE HEMOLYSIS SYMPTOMS AND RENAL DISFUNCTION AFTER TREATMENT OF A SHORT INSTENT TROMBOSED LEFT ILIAC ARTERY AND IS ON ICU NOW. THE PHYSICIAN HAS USED A DVX CATHETER WITH A RUN TIME OF TOTAL 180 SEC INCLUDING FLUSHING. THE TREATMENT WAS TECHNICAL SUCCESSFUL WITHOUT ANY PROBLEM DURING THE PROCEDURE. CREA BEFORE TREATMENT 0.9 GFR >60. CREA AFTER TREATMENT 1.4 GFR 52.3. CONTRAST MEDIA USED, WAS SOLUTRAST 300, 185 ML. VISITED THE CUSTOMER 11/05/2012 09:00. PTS CONDITION IS BETTER NOW BUT STILL CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVX THROMBECTOMY SET ULTRA DVX DXE BAYER INTERVENTIONAL, INC. ULTRA DVX 123916

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention