BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 9530951 · Received December 30, 2019

    Report

    Report Number
    3004742232-2019-00338
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    August 24, 2010
    Report Date
    January 16, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K190634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CSI ID#: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: ATTACHED REFERENCED LITERATURE ARTICLE - ATTACHMENT: [RECORD KORABATHINA (2010) - CCI - OA FOR SYMPTOMATIC LOWER EXTREMITY DISEASE.PDF]

    Description of Event or Problem · 0

    PER THE OPINION OF THE PHYSICIAN, THE DISSECTIONS WERE CAUSED BY THE CSI OAD, MOST OF THE DISSECTIONS WERE TYPE-A, AND THERE WERE NO CLINICALLY SIGNIFICANT CONSEQUENCES TO THE DISSECTIONS. IT WAS NOTED THAT ALL OF THE PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT COMPLICATIONS. PER THE CONTACT LISTED IN THE ARTICLE, NO ADDITIONAL INFORMATION IS AVAILABLE AS THE FACILITY HAS BEEN CLOSED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THE REPORTED OADS WERE UNABLE TO BE REVIEWED, AS THE LOT NUMBERS WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO RESPONSE HAS BEEN RECEIVED FROM THE CONTACT IDENTIFIED IN THE LITERATURE ARTICLE. THEREFORE, AFTER INVESTIGATION, CSI CANNOT OBTAIN ENOUGH INFORMATION ABOUT EACH IDENTIFIED PATIENT AND/OR DEVICE MENTIONED IN ORDER TO PROVIDE A COMPLETE REPORT FOR EACH REPORTABLE EVENT IN THE ARTICLE. THEREFORE, CSI IS SUBMITTING ONE MDR FOR THE MULTIPLE REPORTED EVENTS. DATE OF EVENT: THE DATE ENTERED IS THE DATE OF PUBLICATION. RAVIKIRAN KORABATHINA, "ORBITAL ATHERECTOMY FOR SYMPTOMATIC LOWER EXTREMITY DISEASE," CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 76,3 (2010): 326-32. HTTPS://ONLINELIBRARY.WILEY.COM/DOI/ABS/10.1002/CCD.22508. CSI ID# (B)(4).

    Description of Event or Problem · 1

    KORABATHINA ET AL., 2010 - A LITERATURE ARTICLE WAS PUBLISHED IN 2010 WHICH INDICATED THE FOLLOWING: THIRTY-ONE (31) DISSECTIONS WERE OBSERVED DURING PROCEDURES USING A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). TWENTY-FOUR (24) OF THE DISSECTIONS WERE NOTED AFTER FEMORAL ATHERECTOMY. MOST OF THE DISSECTIONS OCCURRED IN THE FEMORAL BED AND RARELY IN THE TIBIAL ARTERIES. SEVENTEEN (17) OF THE DISSECTIONS REQUIRED STENTING TO RESOLVE THE DISSECTION. FOUR (4) OF THE DISSECTIONS REQUIRED NO TREATMENT. IT WAS NOTED THAT AFTER MULTIVARIATE ANALYSIS, THE PREDICTORS OF DISSECTION WERE: PRESENCE OF DIABETES MELLITUS, A LOWER CROWN-TO-REFERENCE VESSEL DIAMETER RATIO, AND A TOTAL ATHERECTOMY TIME LONGER THAN 360 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326586 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention