BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKONE

    MDR report key: 20395850 · Received October 8, 2024

    Report

    Report Number
    9612164-2024-04587
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    June 17, 2022
    Report Date
    October 8, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    PMA / PMN Number
    K161361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL TITLE: AURYON LASER IN TREATING SYMPTOMATIC INFRAINGUINAL ARTERIAL DISEASE: 1-YEAR OUTCOME ISSN 1557-2501 INDEX J INVASIVE CARDIOL 2022;34(7): E496-E498. DOI: 10.25270/JIC/22.00155. EPUB (B)(6) 2022 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION. 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

    BACKGROUND. THE AURYON 355-NM LASER ATHERECTOMY SYSTEM (ANGIODYNAMICS, INC) SHOWED A LOW RATE OF TARGET-LESION REVASCULARIZATION (TLR) AT 6-MONTH FOLLOW-UP IN THE EX-PAD-03 INVESTIGATIONAL DEVICE EXEMPTION STUDY AND THE AURYON SINGLE-CENTER EXPERIENCE (SCE) IN TREATING INFRAINGUINAL ARTERIES. IN THIS STUDY, WE PRESENT THE 1-YEAR OUTCOMES OF THE AURYON SCE STUDY ON TLR IN ALL COMERS AT A SINGLE CENTER. METHODS. THE AURYON SCE WAS A RETROSPECTIVE STUDY THAT EVALUATED THE OUTCOMES OF ALL COMERS TREATED WITH THE AURYON LASER FOR INFRAINGUINAL ARTERIAL DISEASE. THERE WAS NO TLR SEEN AT 6-MONTH FOLLOW-UP. WE PRESENT THE TLR RATE AT 1 YEAR IN THE SAME COHORT OF PATIENTS. TLR RATES WERE OBTAINED FROM MEDICAL RECORD REVIEW OF PATIENTS ENROLLED IN THE STUDY WHO HAD COMPLETED OFFICE VISIT FOLLOW-UP AT 1 YEAR. SECONDARY ENDPOINTS INCLUDED UNPLANNED MAJOR AMPUTATION AND TOTAL MORTALITY. KAPLAN-MEIER SURVIVAL ANALYSIS WAS PERFORMED TO ESTIMATE THE FREEDOM FROM TLR RATE FOLLOWING INDEX PROCEDURE. STATISTICAL DIFFERENCES WERE ANALYZED FOR ANKLE-BRACHIAL INDEX (ABI) BETWEEN BASELINE AND 1 YEAR. RESULTS. A TOTAL OF (B)(4) PATIENTS ((B)(4) PROCEDURES, (B)(4) LESIONS) WERE ENROLLED. THE MEAN AGE WAS 70.9 ± 10 YEARS, WITH (B)(4) MALES, (B)(4) DIABETICS, AND (B)(4) DEMONSTRATING LIMB ISCHEMIA. OF THE (B)(4) LESIONS, (B)(4) HAD SEVERE CALCIFICATION, (B)(4) WERE CHRONIC TOTAL OCCLUSIONS, AND (B)(4) WERE DE NOVO DISEASE (IN-STENT RESTENOSIS, (B)(4)). STENTING WAS PERFORMED IN (B)(4) LESIONS (B)(4), WITH (B)(4) BAILOUT PROCEDURES. EMBOLIC FILTERS WERE USED IN (B)(4) PROCEDURES (B)(4). THE MAJORITY OF TREATED LESIONS WERE FEMOROPOPLITEAL (B)(4); OF ALL PROCEDURES, (B)(4) HAD (B)(4) OR MORE PRIOR INTERVENTIONS. DRUG-COATED BALLOON USAGE WAS (B)(4) LUTONIX (BD/BARD), (B)(4) IN. PACT (BOSTON SCIENTIFIC), AND (B)(4) BOTH IN ALL LESIONS TREATED. DISTAL EMBOLIZATION OCCURRED IN (B)(4) PROCEDURES (B)(4). AT 1 YEAR, MORTALITY OCCURRED IN (B)(4) PATIENTS (B)(4). OF (B)(4) LIMBS TREATED, (B)(4) HAD MAJOR AMPUTATION AT 1 YEAR. THE PROBABILITY OF FREEDOM FROM TLR WAS (B)(4). CONCLUSION. IN A REAL-WORLD COHORT OF PATIENT WITH COMPLEX DISEASE, THE AURYON LASER HAD EXCELLENT FREEDOM FROM TLR AT 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247418 HAWKONE CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention