BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

    MDR report key: 21975984 · Received May 7, 2025

    Report

    Report Number
    MW5170004
    Event Type
    Death
    Date Received
    May 7, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 6, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS A HISTORY OF STAGE IV METASTATIC RCC. PATIENT RESTARTED CHEMO (LENVATINIB AND EVEROLIMUS) THE WEEK OF (B)(6) 2025. PATIENT STARTED HAVING ABDOMINAL PAIN, SO TOOK LAST DOSE ON (B)(6) 2025. PATIENT THOUGHT SHE STARTED SEEING BLOOD IN STOOL ON (B)(6) 2025, BUT ON (B)(6) 2025 PROGRESSED TO LARGER QUANTITIES. PATIENT ARRIVED AT (B)(6) EMERGENCY DEPARTMENT. PRE-TRANSFUSION HGB WAS 6.2 AND WAS GIVEN LU PRBC. PATIENT WAS TRANSFERRED TO (B)(6) (MEDICAL INTENSIVE CARE UNIT) FOR MANAGEMENT OF UNDIFFERENTIATED SHOCK. UPON TRANSFER TO (B)(6) SHE WAS HDS AND DID NOT REQUIRE FURTHER VASOPRESSORS. STARTED ON BROAD SPECTRUM ANTIBIOTICS. STABILIZED AND TRANSFERRED TO GOLD SERVICE. INTERVENTIONAL GI CONSULTED FOR HER GIB AS HAS HX OF AMPULLARY MASS S/P DUODENAL AND BILIARY STENTS IN (B)(6) AS WELL. AT THAT TIME, AS PT WAS STABLE, RECOMMENDED CLOSE MONITORING. HOWEVER, HAD RECURRENT MELENA, SO UNDERWENT EGD AND C-SCOPE ON (B)(6) FOR RECURRENT MELENA WHICH SHOWED FRIABLE MUCOSA OF MALIGNANT STRICTURE IN DUODENUM, OLD BLOOD/CLOTS IN R>L COLON BUT NO ACTIVE BLEEDING NOTED. FOUND TO HAVE CANDIDEMIA (BLOOD EX 4/1) SO PLACED ON MICAFUNGIN. TTE GROSSLY NORMAL & W/OUT VEGETATION. PORT REMOVED BY IR FOR LINE HOLIDAY ON (B)(6). PALLIATIVE FOLLOWING FOR PAIN MANAGEMENT. RETURNED TO MICU (B)(6) FOR RECURRENT SHOCK, NEW 02 REQUIREMENT & ONE EPISODE OF HEMATEMESIS. INITIALLY IMPROVED W/ IV FLUIDS, PRBC. FOUND TO HAVE NEW BACTEREMIA W/ E. FAECALIS, STARTED ON ZOSYN. PT & FAMILY DISCUSSING POSSIBLE TRANSITION TO HOME HOSPICE AT THAT TIME. HOWEVER, ON (B)(6), PATIENT BECAME HEMODYNAMICALLY UNSTABLE (3 PRESSORS) AFTER MULTIPLE EPISODES OF MELENA, LA UP TO 6. GI RE-ENGAGED. RAD ONE ALSO CONSULTED FOR PALLIATIVE XRT FOR BLEEDING DUODENAL MASS. PT UNDERWENT EGD ON (B)(6) WHICH SHOWED DIFFUSE OOZING OF BLOOD FROM FRIABLE MALIGNANT TISSUE TREATED W/ HEMOSTATIC POWDER. WHILE IN PROCEDURE, PT BECAME HYPOXIC AND HYPOTENSIVE. SHE WAS INTUBATED AND TRANSFERRED BACK TO MICU. AROUND 3PM ON (B)(6) 2025, PT'S PUPILS FOUND TO HAVE ACUTELY FIXED/DILATED PUPILS W/ ABSENT BRAINSTEM REFLEXES. STROKE CODE CALLED. CT BRAIN W/ DIFFUSE ANOXIC INJURY, CEREBRAL EDEMA, PNEUMOCEPHALUS AND POSSIBLE ICH (INTRACEREBRAL HEMORRHAGE). AFTER LEARNING THIS INFORMATION, FAMILY MADE DECISION TO CHANGE CODE STATUS TO DNR WITH PLAN TO TRANSITION TO COMFORT-FOCUSED CARE AFTER OTHER FAMILY MEMBERS HAS BEEN ABLE TO VISIT. ON (B)(6) 2025, PT WAS TRANSITIONED TO COMFORT-FOCUSED CARE AND PALLIATIVELY EXTUBATED. SHE PASSED AWAY AT 1:28PM SURROUNDED BY FAMILY. AUTOPSY WAS DECLINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 5/8/2025 FOR REPORT MW5170004. TOMOSYNTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830933 GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC MUE HOLOGIC, INC. SELENIA DIMENSIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| D EVEROLIMUS.| LENVATINIB.