BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTH 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 3761041 · Received April 21, 2014

    Report

    Report Number
    3004742232-2014-00018
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    January 15, 2015
    Report Date
    April 16, 2014
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K110389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE FOR THE LIBERTY CLINICAL TRIAL, A DISSECTION AND MINOR PERFORATION OCCURRED THAT WERE RESOLVED WITH BALLOON ANGIOPLASTY. THE TARGET LESION WAS A 40MM CTO LESION THAT WAS LOCATED IN THE PERONEAL ARTERY. THE PHYSICIAN USED A 5FR INTRODUCER SHEATH FROM AN ANTEGRADE APPROAC TO ACCESS THE LESION. AFTER COMPLETING TREATMENT OF THE PERONEAL ARTERY USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A TYPE D DISSECTION AND MINOR PERFORATION WERE NOTED. THE PHYSICIAN RESOLVED THEM VIA TWO BALLOON ANGIOPLASTY INFLATIONS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240634 STEALTH 360 ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-125 89542

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention