BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 133MX TISSUE EXPANDER

    MDR report key: 21152305 · Received January 14, 2025

    Report

    Report Number
    9617229-2025-00794
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    November 19, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: ZHENG, E. E., KURUOGLU, D., CESPEDES-GOMEZ, O., FIGUEROA, N. S., VIERKANT, R. A., VIJAYASEKARAN, A., & MARTINEZ-JORGE, J. (2024). ¿THE USE OF CORTIVA® ALLOGRAFT DERMIS IN TWO-STAGED BREAST RECONSTRUCTION: A MATCHED-COMPARISON AND COST ANALYSES STUDY.¿ JOURNAL OF PLASTIC RECONSTRUCTIVE & AESTHETIC SURGERY, 100, 294¿301. HTTPS://DOI.ORG/10.1016/J.BJPS.2024.11.024. ADDITIONAL CONTRIBUTING AUTHORS: EUGENE E. ZHENG: DIVISION OF PLASTIC SURGERY, DEPARTMENT OF SURGERY, MAYO CLINIC, ROCHESTER, MN, USA. DOGA KURUOGLU: DIVISION OF PLASTIC SURGERY, DEPARTMENT OF SURGERY, MAYO CLINIC, ROCHESTER, MN, USA. OMAR CESPEDES-GOMEZ: UNIVERSITY OF MINNESOTA MEDICAL SCHOOL, MINNEAPOLIS, MN, USA. NICOLE SANCHEZ FIGUEROA: DIVISION OF PLASTIC SURGERY, DEPARTMENT OF SURGERY, MAYO CLINIC, ROCHESTER, MN, USA UNIVERSIDAD ESPECIALIDADES ESPIRITU SANTO, SAMBORONDON, ECUADOR. ROBERT A. VIERKANT: DIVISION OF CLINICAL TRIALS AND BIOSTATISTICS, DEPARTMENT OF QUANTITATIVE HEALTH SCIENCES, MAYO CLINIC, ROCHESTER, MN, USA. APARNA VIJAYASEKARAN: DIVISION OF PLASTIC SURGERY, DEPARTMENT OF SURGERY, MAYO CLINIC, ROCHESTER, MN, USA. THE EVENTS OF SEROMA-LATE, WOUND DEHISCENCE, AND INFECTION (UNKNOWN ONSET) ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLY CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: SEROMA-LATE, WOUND DEHISCENCE AND INFECTION (UNKNOWN ONSET).

    Description of Event or Problem · 0

    LITERATURE REVIEW ARTICLE TITLED ¿THE USE OF CORTIVA ALLOGRAFT DERMIS IN TWO-STAGES BREAST RECONSTRUCTION: A MATCHED-COMPARISON AND COST ANALYSIS STUDY.¿ THIS ARTICLE DISCUSSES RISK AND BENEFIT ANALYSIS OF ALLODERM AND CORTIVA ALLOGRAFT DERMIS. NATRELLE® 133 SMOOTH EXPANDERS COMPRISED 90.7% OF THE CASES, WITH THE FOLLOWING STYLES REPRESENTED: MX (73.0%), MV (13.5%), AND FV (2.7%). THE BREAST IMPLANTS INVOLVED FOR THIS RECORD ARE NATRELLE 133 SMOOTH EXPANDERS STYLE MX. 48 PATIENT WERE INVOLVED TOTALING 88 BREASTS. TISSUE EXPANDER MODEL AND SIZE WERE CHOSEN BY THE OPERATING SURGEON. ADM INCORPORATION STATUS AT THE TIME OF SECOND-STAGE RECONSTRUCTION WAS RECORDED BY REVIEWING THE SURGEON¿S OPERATIVE REPORT AND CATEGORIZED AS ¿FULL INCORPORATION,¿ ¿PARTIAL INCORPORATION,¿ OR ¿MISSING¿ IF NOT SPECIFIED IN THE NOTE. MAJOR COMPLICATIONS AFTER EACH STEP OF THE RECONSTRUCTION (THE FIRST AND SECOND STAGES) WERE RECORDED. TISSUE EXPANDERS WERE USED IN THE FIRST STAGE OF RECONSTRUCTION AND INCLUDE THE EVENTS OF SURGICAL SITE INFECTION, SEROMA (DEFINED AS PALPABLE FLUID MANDATING PERCUTANEOUS ASPIRATION OR DRAINAGE) AND OPEN WOUND THAT REQUIRED SURGICAL INTERVENTION. DEVICE SIDE IS UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987875 STYLE 133MX TISSUE EXPANDER EXPANDER: EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention