BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2587600 · Received May 24, 2012

    Report

    Report Number
    3004742232-2012-00059
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE OAD WAS RETURNED WITHOUT THE ORIGINAL GUIDE WIRE. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND THE DRIVESHAFT DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. FURTHER EXAMINATION REVEALED THAT THE CROWN AND DISTAL TIP BUSHING REMAINED INTACT AND UNDAMAGED. BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT AT THE PROXIMAL EDGE OF THE CROWN. THE OUTSIDE DIAMETER OF THE CROWN WAS DIMENSIONALLY INSPECTED USING A CALIBRATED DIAL CALIPER AND MET THE DRAWING SPECIFICATIONS. AT THE CONCLUSION OF THE INVESTIGATION THE REPORTED COMPLAINT OF "TISSUE GATHERED AROUND CROWN" WAS CONFIRMED. BIOLOGICAL MATERIAL WAS OBSERVED ON THE PROXIMAL SIDE OF THE CROWN. HOWEVER, PRODUCT ANALYSIS INDICATED THAT THE DEVICE REMAINED WITHIN SPECIFICATION. NO PRODUCT DEFECT WAS FOUND. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THE OAD LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A COMMON FEMORAL ARTERY (CFA) DISSECTION OCCURRED WHICH WAS REPAIRED WITH STENT. A 0.017" TIP VIPERWIRE WAS ADVANCED AND POSITIONED IN THE LEFT PERONEAL ARTERY. A LARGE EMBOSHIELD FILTER WAS POSITIONED IN THE POPLITEAL FOR DISTAL PROTECTION. THE 2.0MM CSI ORBITAL ATHERECTOMY SYSTEM WAS ADVANCED TO THE PROXIMAL AND MID SFA AND MULTIPLE SANDING RUNS WERE PERFORMED TO TREAT THE LESIONS. THE OAD THEN STALLED AND STOPPED ROTATING. AT THAT POINT, THE DEVICE WAS PULLED BACK INTO THE CFA BUT COULD NOT BE RETRACTED BACK INTO THE SHEATH FOR REMOVAL. THE OAD AND SHEATH WERE REMOVED FROM THE PATIENT'S BODY OVER THE WIRE AS A UNIT LEAVING THE VIPERWIRE AND FILTER IN PLACE. A PIECE OF TISSUE WAS NOTED ADHERED TO THE CROWN OF THE OAD WHEN IT WAS REMOVED. ANGIOGRAPHY REVEALED A DISSECTED MID TO DISTAL CFA WITH POOR FLOW THROUGH THE VESSEL. A 4X80 PTA BALLOON WAS INFLATED SEVERAL TIMES WORKING DISTAL TO PROXIMAL THROUGH THE SFA AND CFA. A 4X120MM BALLOON WAS THEN INFLATED THROUGH THE AREA. THE EMBOSHIELD FILTER WAS REMOVED. A 6X200MM LIFE STENT WAS DEPLOYED IN THE MID-TO-DISTAL SFA, AND A 7X150MM LIFE STENT WAS DEPLOYED IN THE PROXIMAL SFA. A 5X300MM BALLOON WAS ADVANCED INTO THE CFA AND INFLATED TO 10ATMS; HOWEVER, ANGIOGRAPHY REVEALED AN AREA OF SEVERE RESIDUAL STENOSIS WITH AREAS OF DISSECTION FLAPS CAUSING SEVERE STENOSIS OF THE ARTERY WITH POOR FLOW THROUGH THE CFA, OSTIAL SFA, AND THE PROFUNDA ARTERIES. A 5X60MM BALLOON WAS INFLATED TO 6ATMS IN THE CFA. AN 8X60MM STENT WAS DEPLOYED IN THE CFA AND A 5X300MM BALLOON WAS ADVANCED TO THE DISTAL SFA AND WORKING DISTAL TO PROXIMAL, ALL STENTS WERE POST-DILATED. ANGIOGRAPHY CONFIRMED BRISK FLOW THROUGH THE CFA, SFA, AND BELOW THE KNEE ARTERIES, BUT NO FLOW IN THE PROFUNDA. SEVERAL BALLOONS WERE USED TO DILATE THE PROFUNDA ARTERY, INCLUDING A CUTTING BALLOON. AFTER KISSING BALLOON INFLATIONS IN THE PROXIMAL SFA AND OSTIAL PROFUNDA, THE RESIDUAL STENOSIS WAS REDUCED TO 0% AND EXCELLENT FLOW WAS REESTABLISHED TO THE FOOT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-200 60062

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ABOTT VASCULAR NAV6 4-7MM FILTER EMBOSHIELD