BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1132617 · Received August 22, 2008

    Report

    Report Number
    3004742232-2008-00008
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: THE DEVICE WAS DISCARDED BY THE FACILITY AND WAS THEREFORE NOT RETURNED FOR EXAMINATION; THEREFORE AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL DISSECTION AND AN EMBOLISM OCCURRED. THE PHYSICIAN PERFORMED AN ATHERECTOMY/PTA IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE AND AN UNSPECIFIED BALLOON. NO DISTAL EMBOLIZATION PROTECTION SYSTEM WAS USED, BUT THE ANTERIOR TIBIAL ARTERY (AT) REMAINED OPEN/PATENT FOLLOWING THIS INTERVENTION. THE PHYSICIAN THEN PROCEEDED WITH INTERVENTION IN THE AT ARTERY USING THE DIAMONDBACK 1.75 SOLID CROWN OAD. HE PERFORMED ONE PASS AT LOW SPEED, THEN ONE PASS AT MEDIUM SPEED. THE FOLLOW-UP ANGIOGRAM SHOWED NO FLOW IN THE AT ARTERY. THE PHYSICIAN SUSPECTED AN EMBOLISM, SO HE USED A 0.035" EXCHANGE CATHETER FOR ASPIRATION AND FOLLOWED WITH AN INJECTION OF RETAVASE. AFTER 15-20 MINUTES, THERE WAS NO IMPROVEMENT IN FLOW. THE PT HAD A SINGLE PATENT, PERONEAL RUN-OFF VESSEL, SO THE PHYSICIAN ELECTED TO DISCONTINUE ADDITIONAL INTERVENTION. THE RIGHT FOOT WAS SEVERELY MOTTLED WITH NO DORSAL (DP) PULSES PRESENT. THE PHYSICIAN ELECTED TO WAIT/WATCH THE PT IN THE RECOVERY ROOM AND OVER THE NEXT TWO HOURS THE FOOT "PINKED UP A LITTLE." AT 4 PM THAT DAY, THE CSI REPRESENTATIVE RECEIVED A CALL FROM THE PHYSICIAN STATING, HE'D BEEN NOTIFIED THAT THE PATIENT'S ENTIRE RIGHT LEG WAS COLD, SO HE HAD REQUESTED THAT HIS PARTNER TAKE THE PT TO SURGERY TO PERFORM AN EXPLORATORY PROCEDURE. THE SURGEON FOUND THAT THE ENTIRE SFA WAS THROMBOTIC; THEREFORE, HE PERFORMED A FEMORAL CUT-DOWN AND A THROMBECTOMY OF THE SFA AND THE AT ARTERIES. HE ALSO FOUND A RIGHT ILIAC DISSECTION WHICH WAS THOUGHT TO HAVE BEEN CAUSED BY THE 7F INTRODUCER SHEATH (MADE BY ANOTHER MANUFACTURER) WHICH HAD MOVED ABOUT DURING THE INITIAL PROCEDURE. THE SURGEON PLACED AN UNSPECIFIED STENT IN THE RIGHT ILIAC ARTERY AND RESTORED DP PULSES FOR THE PT, BUT THE FOOT REMAINED SEVERELY MOTTLED WITH PURPLE DISCOLORATION OF THE SECOND AND FOURTH TOES ON THE RIGHT FOOT. THE SEVERE MOTTLING EXTENDED THROUGHOUT THE RIGHT FOOT TO THE ANKLE, AND THE PT HAD VERY LITTLE SENSATION ON THE BOTTOM OF THE FOOT. THE SURGEON ATTRIBUTED THESE FINDINGS TO THE EMBOLIZATION. THE PT REMAINED IN THE HOSPITAL FOR ADDITIONAL OBSERVATION. ADDITIONAL INFO HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED DB-SC-175L

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 7F/55CM COOK RAABE INTRODUCER SHEATH| UNSPECIFIED PTA BALLOON| FOX HOLLOW SILVERHAWK ATHERECTOMY DEVICE| 0.035" QUICKCROSS EXCHANGE CATHETER