BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TISSUE EXPANDERS

    MDR report key: 12658448 · Received October 19, 2021

    Report

    Report Number
    1645337-2021-11622
    Event Type
    Injury
    Date Received
    October 19, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, WOUND INFECTION, DEVICE MIGRATION THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING LITERATURE CITATION WAS REVIEWED: ROJAS DP, LEONARDI MC, FRASSONI S, MORRA A, GERARDI MA, LA ROCCA E, CATTANI F, LURASCHI R, FODOR C, ZAFFARONI M, RIETJENS M, DE LORENZI F, VERONESI P, GALIMBERTI VE, INTRA M, BAGNARDI V, ORECCHIA R, DICUONZO S, JERECZEK-FOSSA BA. IMPLANT RISK FAILURE IN PATIENTS UNDERGOING POSTMASTECTOMY 3-WEEK HYPOFRACTIONATED RADIOTHERAPY AFTER IMMEDIATE RECONSTRUCTION. RADIOTHER ONCOL. 2021 AUG 19;163:105-113. DOI: 10.1016/J.RADONC.2021.08.006. EPUB AHEAD OF PRINT. PMID: 34419507. THE ARTICLE FOR THIS COMPLAINT WAS NOT ATTACHED BECAUSE THE FILE SIZE IS TOO LARGE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING LITERATURE CITATION WAS REVIEWED: ROJAS DP, LEONARDI MC, FRASSONI S, MORRA A, GERARDI MA, LA ROCCA E, CATTANI F, LURASCHI R, FODOR C, ZAFFARONI M, RIETJENS M, DE LORENZI F, VERONESI P, GALIMBERTI VE, INTRA M, BAGNARDI V, ORECCHIA R, DICUONZO S, JERECZEK-FOSSA BA. IMPLANT RISK FAILURE IN PATIENTS UNDERGOING POSTMASTECTOMY 3-WEEK HYPOFRACTIONATED RADIOTHERAPY AFTER IMMEDIATE RECONSTRUCTION. RADIOTHER ONCOL. 2021 AUG 19;163:105-113. DOI: 10.1016/J.RADONC.2021.08.006. EPUB AHEAD OF PRINT. PMID: 34419507. OBJECTIVE AND METHODS: TO EVALUATE RECONSTRUCTION FAILURE (RF) RATE IN PATIENTS RECEIVING IMPLANT-BASED IMMEDIATE BREAST RECONSTRUCTION (IBR) AND HYPOFRACTIONATED (HF) POSTMASTECTOMY RADIATION THERAPY (PMRT). STAGE II¿III BREAST CANCER PATIENTS, TREATED WITH HF-PMRT USING INTENSITY MODULATED RADIOTHERAPY WERE STRATIFIED IN TWO GROUPS ACCORDING TO IBR: SINGLE-STAGE DIRECT-TO-IMPLANT (DTI-GROUP) AND TWO-STAGE EXPANDER AND IMPLANT (TE/I-GROUP). IRRADIATED PATIENTS WERE MATCHED WITH NON-IRRADIATED ONES WHO UNDERWENT THE SAME IBR DURING THE SAME PERIOD. PRESCRIPTION DOSE WAS 40.05 GY/15 FRACTIONS TO CHEST WALL AND INFRA/SUPRACLAVICULAR NODAL REGION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MENTOR ROUND SILICONE (PERMANENT IMPLANTS) AND MENTOR CONTOUR PROFILE TISSUE EXPANDERS (TEMPORARY FOR 2 STAGE EXPANDER GROUP). OTHER MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: ANATOMICAL SILICONE ALLERGAN STYLE PROSTHESES (PERMANENT IMPLANTS), ALLERGAN STYLE 133 MV EXPANDERS. THE ARTICLE DOES NOT SPECIFY WHICH MANUFACTURER DEVICES ARE ASSOCIATED WITH THE REPORTED ADVERSE EVENTS; THEREFORE, EXACT QUANTITIES OF IMPACTED PRODUCTS CANNOT BE ACCURATELY DETERMINED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR TE (TISSUE EXPANDER): (QTY 7) SEVERE RT INDUCED SIDE EFFECTS CAUSING FIBROSIS WITH UPWARDS EXPANDER DISLOCATION OR THINNING OF THE MASTECTOMY FLAPS WITH HIGH RISK OF IMPLANT EXPOSURE. (QTY 1) INFECTION TREATED WITH TE IMPLANT REMOVAL. (QTY 2) CAPSULAR CONTRACTURE (GRADE BAKER IV) - NO INFORMATION REGARDING INTERVENTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR PERMANENT IMPLANTS: (QTY 1) EXTRUSION TREATED WITH IMPLANT REMOVAL. (QTY 1) INFECTION TREATED WITH IMPLANT REMOVAL. (QTY 6) CAPSULAR CONTRACTURE (GRADE BAKER IV) - NO INFORMATION REGARDING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558297 UNKNOWN TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention