BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTHERA

    MDR report key: 2685220 · Received August 1, 2012

    Report

    Report Number
    3006560326-2012-00004
    Event Type
    Death
    Date Received
    August 1, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 30, 2012
    Manufacturer
    ULTHERA INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS SUMMARIZED BY (B)(6), M.D. "IT IS IMPROBABLE THAT THE ULTHERA TREATMENT THE DAY PRIOR TO THE DEATH FROM COMPLICATIONS OF RUPTURED INTRACRANIAL ANEURYSM CAUSED THE PROBLEM." "RE: RUPTURED INTRACRANIAL ANEURYSM. SPONTANEOUS RUPTURE OF INTRACRANIAL ANEURYSMS ARE ATTRIBUTED TO HIGH AND FLUCTUATING BLOOD PRESSURE AND/OR MECHANICAL TRAUMA AS CAUSES PRECIPITATING ABNORMAL BLOOD VESSEL DISRUPTION. INTRACRANIAL ANEURYSMS ARE A WEAKENED SEGMENTS OF BLOOD VESSELS, TYPICALLY WEAKENED IN THE MIDDLE, MUSCULAR LAYER OF A BLOOD VESSEL WALL IN THE BRAIN, RESULTING IN AN ABNORMAL WIDENING AND BULGING UNDER THE PRESSURE OF THE BLOOD STREAM. ALTHOUGH, PTS WITH ANEURYSMS MAY BE BORN WITH A WEAKNESS IN ONE OR MORE SPOTS OF THE INTRACRANIAL ARTERIES, IT TAKES YEARS FOR ANEURYSMS TO GROW. THE FOLLOWING FACTORS INCREASE THE RISK OF ANEURYSM RUPTURE: MAJOR CONGENITAL BLOOD VESSEL DEFICIENCY, HIGH BLOOD PRESSURE AND BLOOD PRESSURE VARIATIONS, ATHEROSCLEROSIS, BLOOD STREAM INFECTIONS, SMOKING. ANATOMICALLY, BRAIN ARTERIES ARE LOCATED AT LEAST SEVERAL CENTIMETERS AWAY FROM THE SKULL OR FACIAL SURFACE. THEREFORE, PHYSICAL ENERGY OF ULTRASOUND WHICH PENETRATES AT BEST A FEW MILLIMETERS BELOW THE SKIN SURFACE IS EXTREMELY UNLIKELY TO CAUSE A PROBLEM, A RUPTURE OF A PRE-DISEASED INTRACRANIAL ARTERY." ULTHERA'S MDR REGULATORY DECISION TREE PROCESS FOR REPORTING AE EVENTS DETERMINED THAT THIS EVENT IS/WAS NOT REPORTABLE. HOWEVER, ULTHERA IS REPORTING THE EVENT TO ENSURE COMPLETE COMPLIANCE. DHR WAS REVIEWED AND THE SYSTEM MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN ULTHERAPY PROCEDURE PERFORMED ON MONDAY (B)(6) 2012. THE PT WAS EXERCISING IN THE GYM ON (B)(6) 2012 AND WAS NOT FEELING WELL. WENT TO THE HOSPITAL AND PASSED AWAY FROM A BRAIN ANEURYSM. PHYSICIAN REPORTS THAT IT IS IMPROBABLE THAT THE ULTHERA TREATMENT THE DAY PRIOR TO THE DEATH FROM COMPLICATIONS OF RUPTURED INTRACRANIAL ANEURYSM CAUSED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM GEI ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death