BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASERLIPO SYSTEM

    MDR report key: 14689732 · Received June 14, 2022

    Report

    Report Number
    3011423170-2022-00076
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 19, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    MUU
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE PRODUCT CAN BE RETRIEVED. MORE INFORMATION IS BEING SOUGHT AFTER. THE INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    BAUSCH & LOMB INDIA SALES MANAGER WAS CONTACTED BY A CLINICAL STAFF MEMBER FROM A (B)(6)CENTRE ((B)(6), INDIA) AND MADE AWARE OF A PATIENT DEATH THAT OCCURRED SUBSEQUENT TO A LIPOSUCTION PROCEDURE. THE CLINICAL STAFF REPORTED THEY HEARD FROM THE LOCAL PRINT MEDIA ¿ THAT THE PATIENT DIED DUE TO PULMONARY EDEMA. THE TREATING PHYSICIAN HAS DECLINED TO PROVIDE ANY FURTHER DETAILS ABOUT THE PATIENT AND EVENTS THAT OCCURRED DURING THE PROCEDURE. THE INFORMATION THAT WAS PROVIDED TO THE SALES MANAGER INDICATED THE VASER AMPLIFIER WAS USED DURING THIS PROCEDURE. THERE WERE NO REPORTS OF ANY ISSUES WITH THE DEVICE. EVEN THOUGH THE TREATING PHYSICIAN REPORTED NO ISSUES WITH THE VASER AMPLIFIER DURING THIS EVENT, SOLTA MEDICAL MADE SEVERAL ATTEMPTS TO RETRIEVE THE DEVICE FOR PRODUCT EVALUATION. THE TREATING PHYSICIAN DECLINED RETURN OR SERVICING OF THE DEVICE AND INDICATED THE VASER AMPLIFIER WAS WORKING AS INTENDED. PHYSICIAN IS CURRENTLY USING THE DEVICE DURING TREATMENTS WITHOUT ANY REPORTS OF ISSUES OR EVENTS. THE VASER AMPLIFIER WAS TESTED PRIOR TO TREATMENT AND NO SYSTEM ERRORS OCCURRED WITH THE DEVICE DURING THIS EVENT. THE TREATING PHYSICIAN COMMUNICATED THAT THE VASER AMPLIFIER WAS WORKING AS INTENDED AND DECLINED ANY SERVICING OF THE DEVICE. POST-MARKET ANALYSIS SHOWS THE RISK OF PATIENT MORTALITY FROM A LIPOSUCTION PROCEDURE WHEN USING VASER IS IMPROBABLE. DATING BACK TO JANUARY 2015, IT IS ESTIMATED APPROXIMATELY (B)(4) VASER TREATMENTS WERE PERFORMED. THIS RESULTS IN A MORTALITY RATE OF (B)(4)%. IN THESE ADVERSE EVENTS, IT WAS FOUND THE VASER AMPLIFIER WAS PERFORMING AS EXPECTED. THE ULTRASOUND-ASSISTED LIPOSUCTION PROCEDURE HAS MANY ELEMENTS THAT ARE CONTROLLED BY THE OPERATING SURGEON: AMOUNT OF TUMESCENT SOLUTION INFUSED, AMOUNT OF LIDOCAINE UTILIZED IN TUMESCENT SOLUTION, AMOUNT OF ULTRASONIC FRAGMENTATION TIME, AND THE AMOUNT OF LIPOASPIRATE REMOVED. THE VASER AMPLIFIER IS ONLY USED DURING ULTRASONIC FRAGMENTATION. ADDITIONALLY, GENERAL ANESTHESIA HAS SPECIFIC RISKS WITH REGARDS TO THE ANESTHETIC DRUGS USED, AIRWAY MANAGEMENT, INTRAVENOUS FLUIDS, AND UNTOWARD MEDICAL ISSUES THAT CAN HAPPEN. AN INDEPENDENT MEDICAL REVIEW WAS PERFORMED BY A BOARD-CERTIFIED PHYSICIAN WITH EXTENSIVE VASER EXPERIENCE ON THE LIMITED INFORMATION AVAILABLE REGARDING THIS EVENT. THE REVIEW FOUND IT DOES NOT APPEAR THAT PULMONARY EDEMA WOULD BE ATTRIBUTABLE TO THE VASER AMPLIFIER. THE ROOT CAUSE OF THIS PATIENT¿S DEATH WOULD LIKELY BE RELATED TO OTHER ELEMENTS OF THE LIPOSUCTION PROCEDURE. BASED ON THE INFORMATION COLLECTED, THIS PATIENT¿S DEATH WOULD LIKELY BE RELATED TO ELEMENTS OF THE LIPOSUCTION PROCEDURE UNRELATED TO THE VASER AMPLIFIER. WE HAVE DETERMINED NO FURTHER ACTION IS NECESSARY AT THIS TIME AND SOLTA MEDICAL WILL CONTINUE TO DILIGENTLY MONITOR FOR SIMILAR EVENTS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE VASER AMPLIFIER THAT WAS IN USE (SN (B)(6)), SHOWED THE SYSTEM PASSED ALL REQUIRED FUNCTIONAL AND FINAL TESTING DURING MANUFACTURING. SERVICE RECORDS SHOW THAT THERE HAVE BEEN NO COMPLAINTS OR EVENTS REPORTED FOR THIS VASER AMPLIFIER. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(6). NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT A PATIENT DIED AFTER A LIPOSUCTION PROCEDURE DUE TO THEIR LUNGS BECOMING FILLED WITH WATER. BASED ON AVAILABLE INFORMATION, UNCLEAR IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT¿S OUTCOME. AT THIS TIME, THERE IS NO FURTHER INFORMATION AVAILABLE ABOUT THE EVENT OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836811 VASERLIPO SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU SOLTA MEDICAL, INC 110-0037 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death