BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER CORSÉ FULL HEIGHT 545 S

    MDR report key: 19198788 · Received April 27, 2024

    Report

    Report Number
    3012883202-2024-04217
    Event Type
    Injury
    Date Received
    April 27, 2024
    Date of Event
    February 24, 2024
    Report Date
    April 26, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    UDI-DI
    07445161017567
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 (DOC-037, 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 THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT MASTECTOMY, SENTINEL LYMPH NODE BIOPSY, AND TISSUE EXPANDER (TE) INSERTION FOR LEFT BREAST CANCER. INITIALLY, THE PATIENT TOLERATED THE POSTOPERATIVE TE SKIN EXPANSION WITHOUT COMPLICATIONS. HOWEVER, ON FEBRUARY 23, 2024, THE PATIENT REPORTED SUDDEN CHEST PAIN AND A NOTICEABLE DECREASE IN THE SIZE OF THE BREAST IN THE EXPANSION AREA. CONSEQUENTLY, THE PATIENT PRESENTED AT THE CLINIC ON FEBRUARY 27, 2024. BASED ON THE SYMPTOMS, TE RUPTURE WAS SUSPECTED DUE TO THE OBSERVED DECREASE IN BREAST FULLNESS. DURING AN ASPIRATION PROCEDURE PERFORMED ON THE TE PORT, THE FLUID RETRIEVED WAS YELLOWISH, INDICATING POSSIBLE CONTAMINATION WITH BODY FLUIDS AND SALINE. ON (B)(6) 2024, THE TE WAS REPLACED EARLIER THAN INITIALLY PLANNED DUE TO THESE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870889 MOTIVA FLORA TISSUE EXPANDER CORSÉ FULL HEIGHT 545 S MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC N/A 22081079 07445161017567

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other