BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKONE

    MDR report key: 20950432 · Received December 17, 2024

    Report

    Report Number
    9612164-2024-06021
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    PMA / PMN Number
    K161361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE REF:DOI.ORG/10.5758/VSI.240071. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: THE STUDY TITLED "EFFECTIVENESS OF ATHERECTOMY AND DRUG-COATED BALLOON ANGIOPLASTY IN FEMOROPOPLITEAL DISEASE: A COMPREHENSIVE OUTCOME STUDY" AIMED TO EVALUATE THE OUTCOMES OF ATHERECTOMY AND DCB ANGIOPLASTY FOR TREATING FEMOROPOPLITEAL OCCLUSIVE DISEASE (FPOD). THE TIME FRAME OF THIS STUDY WAS: FROM JUNE 2014 TO JULY 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION.: THE ARTICLE MENTIONS THE USE OF ROTATIONAL ATHERECTOMY DEVICES BY BOSTON SCIENTIFIC AND MEDTRONIC DIRECTIONAL ATHERECTOMY DEVICES TURBOHAWK OR HAWKONE. 1 DEATHS OCCURRED IN THE STUDY POPULATION: NO IN-HOSPITAL MORTALITY OCCURRED BUT THE PATIENT DIED OF ACUTE MYOCARDIAL INFARCTION WITHIN 30 DAYS OF THE PROCEDURE. PATIENT ADVERSE EVENTS INCLUDED: -DEVICE-RELATED COMPLICATIONS OCCURRED IN 10 PATIENTS, WITH 14 COMPLICATIONS WHICH INCLUDED ASPIRATION THROMBECTOMY, BAIL-OUT STENTING DUE TO FLOW-LIMITING DISSECTION, BALLOON ANGIOPLASTY, AND BALLOON TAMPONADE DUE TO RUPTURE. -ONE PATIENT UNDERWENT OPEN SURGICAL EMBOLECTOMY DUE TO MACROEMBOLISM. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279775 HAWKONE CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male