BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11351152 · Received February 19, 2021

    Report

    Report Number
    9617229-2021-01835
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    September 18, 2020
    Report Date
    September 24, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FI RESULTS: TRAINING RECORDS OF THE PERSONNEL INVOLVED IN THE SHELL FABRICATION OF WORK ORDER 3130832 WERE REVIEWED AND IT WAS CONFIRMED THAT THEY WERE TRAINED IN THE APPLICABLE REVISION OF QA155 (SHELL INSPECTION PROCEDURE) AT THE TIME OF PERFORMING THE ACTIVITIES RELATED TO THOSE PROCEDURES. IN ADDITION, TRAINING RECORDS OF THE PERSONNEL INVOLVED IN THE ASSEMBLY OF WORK ORDER (B)(4) WERE REVIEWED AND IT WAS CONFIRMED THAT THEY WERE TRAINED IN THE APPLICABLE REVISION OF MP-810 (SINGLE-LUMEN GEL-IMPLANT AND SIZER SHELL PATCHING), MP-818 (GEL FILLING AND CURING OF IMPLANTS) AND MP-825 (PRIMARY PACKAGING) AT THE TIME OF PERFORMING THE ACTIVITIES RELATED TO THOSE PROCEDURES. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H.6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5 D9 G1 H3 H6. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, WEAR ABRASION, OBSERVED SPLIT IN PATCH AREA, IT IS OUT OF SPECIFICATION PER QA 199.04 REV 8.0 AND CREASES FOLD. CLOUDY IN THE GEL OBSERVED AFTER AUTOCLAVE CYCLE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: SPLIT IN PATCH AREA DUE TO A WORKMANSHIP. FURTHER INVESTIGATION SUMMARY: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH WORK ORDER (B)(4) WERE RELEASED IN ACCORDANCE WITH THE CURRENT MANUFACTURING PROCEDURES, AND NO ANOMALIES WERE FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED IN THE LABORATORY, IT WAS FOUND A SPLIT IN PATCH AREA (SS) WHICH IS CONSIDERED AS WORKMANSHIP ACCORDING THE QA199.04. THIS FINDING IS NOT RELATED WITH THE REPORTED EVENT. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED, AND THE EVENT OF SPLIT IN PATCH AREA IS A KNOWN EVENT, FOR WHICH MANUFACTURING PROCESS CONTROLS AND INSPECTIONS ARE STABLISHED TO REDUCE THE INCIDENCE OF THIS DEFECT. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH SPLIT IN PATCH AREA WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE (GRADE III)" AND "SUPERIOR MALPOSITION". THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE (GRADE III) AND MALPOSITION. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "SUPERIOR MALPOSITION."

    Additional Manufacturer Narrative · 1

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE, BAKER GRADE III.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE (GRADE III). THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245220 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3130832

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention