BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10372373 · Received August 6, 2020

    Report

    Report Number
    2916596-2020-03902
    Event Type
    Death
    Date Received
    August 6, 2020
    Date of Event
    July 22, 2020
    Report Date
    September 22, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENT AND PATIENT OUTCOME, AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LVAS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT WAS ADMITTED WITH A SUBDERMAL HEMATOMA. THE PATIENT WAS NOTED TO BE UNCONSCIOUS AT THE TIME OF ADMISSION AND WAS NOT RESPONDING NEUROLOGICALLY. CT SCANS WERE PERFORMED WHICH CONFIRMED A LEFT FRONTO-TEMPOROPARIETAL ACUTE SUBDURAL HEMATOMA. ALL ANTICOAGULANTS WERE STOPPED AND ON (B)(6) 2020, THE PATIENT UNDERWENT SURGERY FOR LEFT FRONTO-TEMPOROPARIETAL DECOMPRESSION CRANIOTOMY AND EXCAVATION OF THE HEMATOMA. DURING SURGERY, DARK COLORED CLOTS OF HEMATOMA WERE REMOVED MEASURING AROUND 100 CC. FOLLOWING SURGERY, THE PATIENT CONTINUED TO EXPERIENCE BLEEDING AND ON (B)(6) 2020, SURGERY WAS PERFORMED WHICH REVEALED A LARGE SUBGALEAL HEMATOMA EXTRADURALLY. THE HEMATOMA, MEASURING APPROXIMATELY 1500 CC, WAS COMPRESSING THE BRAIN PARENCHYMA. THE HEMATOMA WAS EXCAVATED, AND ACUTE OOZING WAS PRESENT FROM THE DURAL LEAFLETS. ON (B)(6) 2020, CT SCANS REVEALED MULTIPLE NEW EXTRA AXIAL HEMATOMAS. SURGERY WAS AGAIN PERFORMED TO EXPLORE THE NEW HEMATOMAS, WHICH WERE DISSECTED WITHIN THE LEFT TEMPORAL BRAIN PARENCHYMA. THE HEMATOMA WAS APPROXIMATELY 6.6 BY 4.1 CM, HOWEVER THE BLEED WITHIN THE LEFT TENTORIAL AND INTERHEMISPHERIC AREAS INCREASED IN THICKNESS. ON (B)(6) 2020, THE PATIENT DEVELOPED BRADYCARDIA, ARRESTED AND EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS HEMORRHAGIC STROKE. PER THE VAD COORDINATOR, THE PATIENT¿S DEATH WAS DEVICE RELATED; HOWEVER, THEY ALSO REPORTED THAT THE DEVICE WAS OPERATING AS EXPECTED. REPORTEDLY THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO PRODUCT AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU LISTS STROKE, BLEEDING, CARDIAC ARRHYTHMIA, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE HEARTMATE 3 LVAS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 19NOV2019. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL AND LATER SHIFTED TO (B)(6) HOSPITAL. THE PATIENT WAS UNCONSCIOUS ON ADMISSION. A CT SCAN REVEALED A LEFT FRONTO-TEMPROPARIETAL ACUTE SUBDURAL HEMATOMA. ON (B)(6) 2020 THAT PATIENT UNDERWENT SURGERY FOR THE HEMATOMA AND A DECOMPRESSION CRANIOTOMY AND EVACUATION OF THE HEMATOMA WAS PERFORMED. DARK COLORED CLOTS OF THE HEMATOMA WERE REMOVED AND MEASURED ABOUT 100CC. ON (B)(6), THE PATIENT WAS RE-EXPLORED AND FOUND A LARGE SUBGALEAL HEMATOMA EXTRADURALLY COMPRESSING THE BRAIN PARENCHYMA MEASURING APPROXIMATELY 1500 CC. THE HEMATOMA WAS EVACUATED AND THERE WAS ACUTE OOXING FROM THE DURAL LEAFLETS DIFFUSELY ALL AROUND. ON (B)(6) 2020, THE PATIENT HAD ANOTHER CT SCAN THAT SHOWED MULTIPLE EXTRA AXIAL HEMATOMAS. THE NEW EXTRA HEMATOMA IN THE LEFT TEMPORAL REGION WHICH WAS DISSECTED IN TO THE LEFT HEMATOMA BRAIN PARENCHYMA. THE HEMATOMA WAS APPROXIMATELY 6.6 X 4.1 CM. HOWEVER, THE LEFT TENORIAL AND INTERHEMISPHERIC BLEED WAS FOUND TO BE INCREASED IN THICKNESS.

    Additional Manufacturer Narrative · 1

    (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH A SUBDURAL HEMATOMA. THE PATIENT WAS TAKEN OFF ANTICOAGULANTS AND SURGERY WAS PERFORMED FOR THE HEMATOMA. THE PATIENT REQUIRED RE-EXPLORATIONS DUE TO BLEEDING POST SURGERY. ALL ANTI-COAGULANTS WERE STOPPED. ON (B)(6) 2020 THE PATIENT DEVELOPED BRADYCARDIA AND ARRESTED. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841216 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7025145

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| R