BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 10659965 · Received October 10, 2020

    Report

    Report Number
    1645337-2020-12880
    Event Type
    Injury
    Date Received
    October 10, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317024330
    PMA / PMN Number
    K161176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, IT WAS FOUND THAT PMA/510K WAS OMITTED ON THE INITIAL REPORT. THE PMA/510K FOR THE REPORTED DEVICE IS K161176. THE RELEVANT FIELD HAS BEEN UPDATED. IT WAS FOUND THAT THE PRODUCT RETURN WAS OMITTED ON THE PREVIOUS REPORT. THE SUSPECTED MEDICAL DEVICE WAS RETURNED ON (B)(6) 2020. THE RELEVANT FIELDS HAVE BEEN UPDATED. THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 11-NOV-2020, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS COMPLETED. INVESTIGATION SUMMARY : DURING VISUAL EVALUATION OF THE DEVICE, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED ON THE DEVICE, AND THE RESULT REVEALED A TEAR AT THE JUNCTURE OF THE SHELL AND FRONT PATCH. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE DEVICE, AND THE CAUSE OF THE RUPTURE COULD NOT BE IDENTIFIED. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 16-NOV-2020, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE REVISION SURGERY AND REPLACEMENT DEVICE. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 600CC RTOURA BREAST TISSUE EXPANDER (CATALOG #: SMXP140RH, SERIAL #: (B)(4)). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH A 600CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF EVENT, THE PATIENT¿S SURGEON COMPLETED TWO FILLS INTO THE EXPANDER, AND THE PATIENT WAS LESS THAN TWO MONTHS IN FOR THE EXPANSION PROCESS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124508 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS SMXP140RH 9401236 00081317024330

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention