BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET ULTRA DVX

    MDR report key: 1246399 · Received November 20, 2008

    Report

    Report Number
    2183460-2008-00012
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    November 20, 2008
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORTED EVENT WAS THAT THE PT REQUIRED ONE UNIT OF BLOOD DUE TO A HEMOGLOBIN VALUE OF 7.8 THIRTEEN DAYS POST ANGIOJET THROMBECTOMY. THERE WAS NO OTHER TREATMENT REQUIRED. THE PT HAD NO SEQUELAE TO THIS EVENT AND THE EVENT WAS CONSIDERED RESOLVED. THE ATTENDING PHYSICIAN HAD DETERMINED THAT THE EVENT WAS PROBABLY RELATED TO THE ANGIOJET CATHETER AND TO THE PROCEDURE. POSSIS STARTED AN INVESTIGATION INTO THIS EVENT SINCE ANGIOJET RELATED RENAL EVENTS ASSOCIATED WITH HEMOLYSIS IS TYPICALLY RESOLVED IN 24-48 HOURS. IN THIS CASE, WE WANTED FURTHER F/U WITH THE PHYSICIAN TO UNDERSTAND WHY HE THOUGHT THE EVENT WAS RELATED TO THE ANGIOJET THERAPY AS WELL AS ANY ADDITIONAL PT INFORMATION THAT COULD EXPLAIN THE DECREASED HEMOGLOBIN. ON THE DAY OF THE ANGIOJET PROCEDURE, THE PT HAD RECEIVED N-ACETYLCYSTEINE (MUCOMYST) AND SODIUM BICARB PRIOR TO THE PROCEDURE WITH 130 MILS OF CONTRAST. THERE WERE 2 FAILED ATTEMPTS (LEFT AND RIGHT FEMORAL) FOR VASCULAR ACCESS PRIOR TO POWER PULSE DELIVERY OF 20 ML OF TPA WITH A WAIT TIME OF 20 MINUTES. ANOTHER 2 PASSES WERE MADE FOR A TOTAL VOLUME OF 246 MLS DURING THE THROMBECTOMY PROCEDURES. A CT SCAN WAS PERFORMED POST PROCEDURE WITHOUT CONTRAST. ONE DAY AFTER THE ANGIOJET THERAPY, THE PHYSICIAN NOTED THAT THE PT HAD ACUTE RENAL FAILURE MOST LIKELY SECONDARY TO ACUTE TUBULAR NECROSIS OBSTRUCTION. AN ULTRASOUND RULED OUT OBSTRUCTION. THE PT BEGAN DIALYSIS THREE DAYS LATER (FOUR DAYS POST ANGIOJET THERAPY). THE PT'S HEMOGLOBIN STARTED TO DECREASE AFTER DIALYSIS. THIRTEEN DAYS AFTER ANGIOJET THERAPY, AND NINE DAYS AFTER DIALYSIS HAD BEGUN, THE PT'S HEMOGLOBIN DROPPED TO 7.8 G/DL REQUIRING A TRANSFUSION OF ONE UNIT PACKED CELLS. THIS EVENT MAY BE DIRECTLY RELATED TO THE EARLIER DIALYSIS EVENT (2183460-2008-00011), SINCE THE HEMOGLOBIN STARTED TO DECREASE THE DAY AFTER DIALYSIS BEGAN. THE DECREASE IN HEMOGLOBIN AS A RESULT OF ANGIOJET THERAPY MAY BE INCONCLUSIVE SINCE IT OCCURRED THIRTEEN DAYS POST ANGIOJET THERAPY. ANGIOJET CAN CAUSE HEMOLYSIS BUT IT TYPICALLY IS RESOLVED IN 24-48 HOURS. HOWEVER, THE RENAL FAILURE AND SUBSEQUENT DIALYSIS MAY HAVE BEEN ASSOCIATED WITH THE ANGIOJET PROCEDURE AND THE DIALYSIS MAY HAVE CONTRIBUTED TO THE DECREASE IN HEMOGLOBIN AND THE NEED FOR THE 1 UNIT OF PACKED CELLS. AS SUCH, THIS EVENT SHOULD BE CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    PT IS A (B) (6), WHITE MALE WHO INITIALLY PRESENTED ON (B) (6) 2008, WITH SLI. PT WAS PREVIOUSLY DIAGNOSED WITH PAD AND PREVIOUSLY UNDERWENT AORTO-BIILIAC GRAFT APPROX 8-10 YEARS AGO. PT HAS A HISTORY OF HYPERTENSION (BASELINE BLOOD PRESSURE 184/90) AND NON-INSULIN DEPENDENT DIABETES WITH HYPERLIPIDEMIA. ONSET OF S/S WAS <24 HOURS AND LEFT LOWER LIMB WITH AORTO-BIILIAC BYPASS GRAFT WAS THREATENED IMMEDIATELY WITH COMPLETE OCCLUSION. PT UNDERWENT THROMBECTOMY. ON FINAL ANGIOGRAPHIC ASSESSMENT, THE GRAFT WAS PATENT. ON (B) (6) 2008, THE PT'S HEMOGLOBIN DROPPED TO 7.8 G/DL. PT WAS TRANSFUSED ONE UNIT OF BLOOD THAT RESULTED IN NO SEQUELAE AND EVENT WAS CONSIDERED RESOLVED. PHYSICIAN HAS DETERMINED THAT THIS WAS PROBABLY RELATED TO THE ANGIOJET CATHETER AND PROBABLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA DVX EMBOLECTOMY CATHETER DXE POSSIS MEDICAL, INC. 106552-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention