BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 18166000 · Received November 17, 2023

    Report

    Report Number
    3012883202-2023-03553
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    August 1, 2023
    Report Date
    May 20, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ANALYZING THE REPORT AND THE UNIT RECEIVED, ONLY A RUPTURE IN THE SILICONE WRAP OF THE DEVICE INVOLVED WAS CONFIRMED. THE DEVICE SENT FOR INVESTIGATION WAS THOROUGHLY ANALYZED TO DETERMINE THE CAUSE OF THE EVENT: VISUAL INSPECTION WITH THE MICROSCOPE SHOWED TRACES IN THE SILICONE SHELL OF THE IMPLANT, CONSISTENT WITH THOSE OF A SHARP INSTRUMENT REPRODUCED IN OUR LABORATORY, BEING DIFFERENT FROM THE PATTERN RESULTING FROM SPONTANEOUS TEARING OF THE IMPLANT SHELL. THE ELONGATION TESTS CONFIRM THAT THE SHELL COMPLIES WITH THE SPECIFICATIONS OF INTERNATIONAL STANDARDS. THERE WERE NO ANOMALIES IN THE MANUFACTURING PROCESS THAT MAY HAVE AFFECTED THIS PARTICULAR LOT. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. DEFLATION IS A KNOW RISK OF IMPLANTATION WITH TISSUE EXPANDERS AND IT IS DOCUMENTED IN THE MOTIVA FLORA TISSUE EXPANDER DIRECTIONS FOR USE ((B)(4), REVISION 6),AS FOLLOWS: "RUPTURE/DEFLATION: TISSUE EXPANDER RUPTURE/DEFLATION OCCURS WHEN THE SHELL DEVELOPS A TEAR OR A HOLE. RUPTURE/DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT INCREASES IN LIKELIHOOD THE LONGER THE BREAST TISSUE EXPANDER IS IN PLACE. THE FOLLOWING MAY CAUSE EXPANDERS TO RUPTURE/DEFLATE: DAMAGE BY SURGICAL INSTRUMENTS, DEVICE STRESS AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE DEVICE, PLACEMENT, OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE EXPANDER'S SHELL, TRAUMA AND SEVERE CAPSULAR CONTRACTURE. EXPANDER DEFLATION MAY OCCUR IF THERE IS LEAKAGE OF SALINE SOLUTION WHEN INSERTING THE NEEDLE OUT OF THE INJECTION AREA DURING FILLING; ANOTHER POSSIBLE CAUSE IS A DAMAGED BREAST TISSUE EXPANDER ENVELOPE." AS STATED IN THE LITERATURE, "A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE." (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128.) ADDITIONALLY, RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE IMPLANT, AS STATED ABOVE. IN CONCLUSION, IT IS DETERMINED THAT THE PROBABLE CAUSE OF BREAKAGE FOR THIS EVENT WAS A CUT POTENTIALLY CAUSED BY A SHARP INSTRUMENT USED CAUSING A WEAKENING OF THE SHELL.

    Additional Manufacturer Narrative · 0

    THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICITY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. ADDITIONALLY, NO ADVERSE OUTCOME REGARDING THE PATIENT HAS BEEN REPORTED, TO DATE, MOTIVA FLORA TISSUE EXPANDER HAS NOT RECEIVED, THEREFORE AN ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED.IN ABSENCE OF THE DEVICE, DEFINITIVE CAUSE OF THE DEFLATION CANNOT BE DETERMINED. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION IS ONGOING AND THE INVESTIGATION IS IN PROCESS. DEFLATION IS A KNOW RISK OF IMPLANTATION WITH TISSUE EXPANDERS AND IT IS DOCUMENTED IN THE MOTIVA FLORA TISSUE EXPANDER DIRECTIONS FOR USE ((B)(4), REVISION 6),AS FOLLOWS: "RUPTURE/DEFLATION: TISSUE EXPANDER RUPTURE/DEFLATION OCCURS WHEN THE SHELL DEVELOPS A TEAR OR A HOLE. RUPTURE/DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT INCREASES IN LIKELIHOOD THE LONGER THE BREAST TISSUE EXPANDER IS IN PLACE. THE FOLLOWING MAY CAUSE EXPANDERS TO RUPTURE/DEFLATE: DAMAGE BY SURGICAL INSTRUMENTS, DEVICE STRESS AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE DEVICE, PLACEMENT, OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE EXPANDER'S SHELL, TRAUMA AND SEVERE CAPSULAR CONTRACTURE. EXPANDER DEFLATION MAY OCCUR IF THERE IS LEAKAGE OF SALINE SOLUTION WHEN INSERTING THE NEEDLE OUT OF THE INJECTION AREA DURING FILLING; ANOTHER POSSIBLE CAUSE IS A DAMAGED BREAST TISSUE EXPANDER ENVELOPE." IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IF AND WHEN THE TISSUE EXPANDER IS RECEIVED AND THE ANALYSIS OF THE DEVICE HAS BEEN COMPLETED THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PHYSICIAN THAT AFTER IMPLANTATION OF THE RIGHT TISSUE EXPANDER, WEEKLY EXPANSION BEGAN. HOWEVER, THE UNIT PRESENTED PERSISTENT DEFLATION AND THE EXPANDER WAS REPLACED WITH A PROSTHESIS. DURING REVISION SURGERY IT WAS NOTED THAT THE EXPANDER HAD BEEN RELEASED FROM THE SUTURE FIXATION AND HAD MIGRATED TO THE LATERAL AND SUBCUTANEOUS SPACE WITH PLICATION OF THE UPPER POLE OVER THE (NEEDLE STOP). FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744605 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC N/A 22101264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other