BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTACT CONSOLE

    MDR report key: 7251405 · Received February 8, 2018

    Report

    Report Number
    1226420-2018-00030
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    June 1, 2010
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ARTICLE: MARGIN-FREE EXCISION OF SMALL SOLID BREAST CARCINOMAS USING THE INTACT BREAST LESION EXCISION SYSTEM®: IS IT FEASIBLE? DOI 10.1007/S12282-017-0802-Z BACKGROUND: THE BREAST LESION EXCISION SYSTEM ® (BLES) IS A STEREOTACTIC VACUUM-ASSISTED BREAST BIOPSY DEVICE THAT UTILIZES RADIOFREQUENCY IN ORDER TO EXCISE NON-PALPABLE MAMMOGRAPHIC LESIONS FOR PATHOLOGIC DIAGNOSIS. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF BLES IN PERFORMING COMPLETE, MARGIN-FREE EXCISIONS OF SMALL SOLID CARCINOMAS. RESULTS: DUCTAL CARCINOMA IN SITU (DCIS) WAS DIAGNOSED IN 5 PATIENTS AND INVASIVE CARCINOMA (IC) IN 45 PATIENTS, AT PRIMARY BLES PATHOLOGY REPORT. TUMOR-FREE RESECTION MARGINS (<(><<)> 0.5 AND <(><<)> 1 MM) WERE ACCOMPLISHED IN ONLY 8/24 SUBCENTIMETER CASES (33.3%). ABSENCE OF RESIDUAL DISEASE UPON SURGICAL EXCISION WAS CONFIRMED IN 23/24 SUBCENTIMETER CASES (95.8%) AND 2/26 OF THE CASES MEASURING > 1 CM (7.69%). STATISTICAL ANALYSIS REVEALED THAT MAMMOGRAPHIC SIZE WAS THE ONLY SIGNIFICANT PROGNOSTIC FACTOR FOR COMPLETE EXCISION (I.E., WITH NO RESIDUAL DISEASE IN THE BIOPSY CAVITY) OF A MALIGNANT LESION. CONCLUSIONS OUR RESULTS INDICATE THAT IT IS POSSIBLE, WHEN USING THE BLES DEVICE, TO COMPLETELY EXCISE SMALL (= 10 MM) BREAST CARCINOMAS THAT APPEAR RADIOLOGICALLY AS SOLID LESIONS. THIS SUBSET OF PATIENTS SHOULD BE INVESTIGATED REGARDING THE THERAPEUTIC POTENTIAL OF THIS METHOD. COMPLICATIONS WERE ENCOUNTERED AFTER THE PROCEDURE IN 2 CASES (4%) AND INCLUDED ONE CASE WITH A HEMATOMA THAT WAS MANAGED CONSERVATIVELY, AND ONE POST-PROCEDURAL CASE OF A WOUND INFECTION THAT WAS TREATED WITH ORAL ANTIBIOTICS. THERE WERE NO PATIENT IDENTIFIERS WITHIN THE ARTICLE, THEREFORE THE PATIENTS WILL BE REPORTED AS A WHOLE AND NO OTHER RECORDS WILL BE CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100637 UNKNOWN INTACT CONSOLE INSTRUMENT, BIOPSY KNW MEDTRONIC ADVANCED ENERGY, LLC MAE UNK INTACT GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention