BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19094233 · Received April 11, 2024

    Report

    Report Number
    9617229-2024-06343
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    February 15, 2024
    Report Date
    April 11, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1. PHONE NUMBER: (B)(6); CONTINUED E.1. FAX NUMBER: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH LOT NUMBER 2243280 WERE RELEASED IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ADDITIONALLY, NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT. ACCORDING TO THE COMPLAINT REVIEW THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS IN THE DEVICE ANALYSIS LABORATORY. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED IN CHL-BI FAMILY (V14.0), AND THE EVENT OF BIA-ALCL IS A KNOWN HAZARD FOR BREAST IMPLANTS. PER EVALUATION PERFORMED IN THIS INVESTIGATION AND, BASED ON THE CODING MATRIX FOR MEDICAL DEVICES AND HUMAN TISSUE QPP07-01-003-G17 (V3.0) THIS CODE IS CLASSIFIED AS MEDICAL EVENT; ALSO, ACCORDING TO THE PROCEDURE QPP07-01-003-W37 (V4.0) THIS EVENT IS NOT CLASSIFIED AS A POTENTIAL HIGH IMPACT COMPLAINT, THEREFORE THIS CASE IS NOT CONFIRMED AS HIGH IMPACT COMPLAINT, AND NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH LYMPHOMA - ALCL WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. THE EVENTS OF "LYMPHOMA-ALCL" AND "LUMP/NODULE" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE 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. REASON FOR REOPERATION: BIA-ALCL; "LESION."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURVEILLANCE FOR HODGKIN'S LYMPHOMA (NOT DEVICE-RELATED), A LESION APPEARED IN THE LEFT BREAST. A BIOPSY CARRIED OUT, "DID CONDITION OF A LYMPHOMA WHICH REQUIRED A TOTAL CAPSULECTOMY WITH REMOVAL OF THE PROSTHESIS TO DEFINITIVELY CHARACTERIZE A ANAPLASTIC LARGE CELL LYMPHOMA." PATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN RECEIVED. DEVICE HAS BEEN EXPLANTED. TOTAL CAPSULECTOMY WAS PERFORMED AND PATIENT WILL RECEIVE ADJUVANT CHEMOTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470896 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2243280

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Life Threatening