BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 14518027 · Received May 26, 2022

    Report

    Report Number
    1645337-2022-06170
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 6, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317024392
    PMA / PMN Number
    K161176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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: TISSUE EXPANDER DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED A DEVICE FOR THIS COMPLAINT ON 27-MAY-2022. IT IS AN ARTOURA BREAST TISSUE EXPANDER 650CC DEVICE, CATALOG # SMXP130RUH, LOT #9559178, UDI #(B)(4), 510(K) #K161176. ON 07-JUN-2022, MENTOR BECAME AWARE THAT THIS RETURNED DEVICE BELONGS TO THIS COMPLAINT. ADDITIONALLY, 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. 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 05-SEP-2022, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE TISSUE EXPANDER DID NOT APPEAR TO BE FILLING CORRECTLY IN CLINIC. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE HAD AN AREA OF DELAMINATION AT THE UNION BETWEEN THE FRONT PATCH AND SHELL ON THE ANTERIOR VIEW, WITHOUT LEAKAGE. LEAK TESTING WAS PERFORMED, ACCORDING TO WITH THE MENTOR PROCEDURE, AND IT REVEALED A TEAR ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 0.1 CM. IN ADDITION, NO ADDITIONAL LEAKS WERE DETECTED. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE TEAR. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE TISSUE EXPANDER SHELL. MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE TISSUE EXPANDER COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS, OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH MENTOR¿S QUALITY SYSTEM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INVESTIGATION WAS PERFORMED AND IT WAS CONCLUDED THAT THE PROCESS CONTROLS AND DATA RECORDS COLLECTED FOR THE "TISSUE EXPANDER DID NOT APPEAR TO BE FILLING CORRECTLY" REPORTED ON PRODUCT COMPLAINT WAS NOT ABLE TO BE CONFIRMED AS MANUFACTURING DEFECT. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THE RIGHT BREAST TISSUE EXPANDER WOULD NOT FILL CORRECTLY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664632 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS SDC130UH 9559178 00081317024392

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention