BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PLUS

    MDR report key: 20890673 · Received December 10, 2024

    Report

    Report Number
    1282497-2024-20036
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    September 28, 2024
    Report Date
    December 10, 2024
    Manufacturer
    COVIDIEN LLC
    Product Code
    MCW
    PMA / PMN Number
    K170191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE REF: DOI.ORG/10.1111/JCH.14908 A2: AVERAGE AGE A3A: MAJORITY SEX. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: 'A RETROSPECTIVE COMPARATIVE STUDY OF MID-TERM OUTCOMES OF ATHERECTOMY, DRUG-COATING BALLOON ANGIOPLASTY, AND PLAIN OLD BALLOON ANGIOPLASTY FOR ISOLATED ATHEROSCLEROTIC POPLITEAL ARTERY LESIONS' . THE TIME FRAME OF THIS STUDY WAS: AUGUST 2017 TO AUGUST 2022 . MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION: YES, MULTIPLE MANUFACTURERS¿ DEVICES WERE USED, LASER EXCISION SYSTEMS, NITINOL STENTS AND EMBOLIC PROTECTION DEVICES. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SPIDER FX, TURBO-HAWK PLAQUE EXCISION SYSTEM, AND MEDTRONIC NITINOL STENTS. THE TECHNICAL SUCCESS RATE OF THE THREE GROUPS WAS 100% AND THERE WERE NO DEATHS WITHIN 30 DAYS OF THE SURGERY. AMONG PATIENT ADVERSE EVENTS INCLUDED: FLOW-LIMITING DISSECTIONS OR ELASTIC RECOIL, THESE ISSUES WERE ADDRESSED THROUGH THE APPLICATION OF BAILOUT STENTING INCLUDING MEDTRONIC NITINOL STENTS. RESTENOSIS AND/OR RE-OCCLUSION. CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION AND AMPUTATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522567 TURBOHAWK PLUS CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SPIDER FX EMBOLIC PROTECTION, NITINOL STENT,