BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10712835 · Received October 21, 2020

    Report

    Report Number
    2916596-2020-05175
    Event Type
    Death
    Date Received
    October 21, 2020
    Date of Event
    October 7, 2020
    Report Date
    March 25, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED HEMORRHAGIC STROKE AND SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IN ADDITION, A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT BE CONCLUSIVELY ESTABLISHED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED, AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1: OF THIS IFU LISTS STROKE, INFECTION, AND SEPSIS AS ADVERSE EVENTS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6: OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THIS IFU, INCLUDING A SECTION ENTITLED "CONTROLLING INFECTION". THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THIS HANDBOOK ALSO CONTAINS INFORMATION ABOUT PREVENTING INFECTION. 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 EXPIRED ON (B)(6) 2020 ,DUE TO HEMORRHAGIC STROKE. ON (B)(6) 2020, THE PATIENT HAD A TEMPORARY HEMODIALYSIS CATHETER REMOVED, DUE TO RENAL RECOVERY. AND SUBSEQUENT, END OF HEMODIALYSIS TREATMENT. THE SAME DAY, HE WAS SEEN IN THE VENTRICULAR ASSIST DEVICE (VAD) CLINIC FOR FOLLOW-UP. AND RECEIVED A FLU SHOT AND WOUND VACUUM ASSISTED CLOSURE REMOVED FROM RIGHT GROIN. ON (B)(6) 2020, THE PATIENT WENT TO THE EMERGENCY ROOM WITH A FEVER OF MAXIMUM TEMPERATURE 102.3 F PRESENT SINCE (B)(6) 2020. PATIENT HAD BEEN TAKING TYLENOL EVERY (B)(6) HOURS AND HAD BEEN COUGHING UP PHLEGM. IN THE EMERGENCY ROOM, THE PATIENT WAS FOUND, TO HAVE ELEVATED INTERNATIONAL NORMALIZED RATIO (INR) OF 5.5 AND ELEVATED LACTIC ACID. THE VAD TEAM TEAM REWORKED THE ANTICOAGULANT TREATMENT PROTOCOL FOR A LOWER INR GOAL, FOR THIS PATIENT OVER THE PREVIOUS MONTH. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPTICEMIA AND SUPRA THERAPEUTIC INR. IN THE EARLY EVENING, THE PATIENT COMPLAINED OF A HEADACHE, THEN LEFT ARM AND LEG NUMBNESS, INABILITY TO STAND, AND THEN SLURRING WORDS. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE PATIENT'S HEAD SHOWED A VERY LARGE RIGHT-SIDED INTRAPARENCHYMAL HEMORRHAGE. THE PATIENT WAS TREATED WITH ANTIEPILEPTIC THERAPY AND MANNITOL. THE INR WAS REVERSED WITH VITAMIN K, KCENTRA, AND FRESH FROZEN PLASMA. THE PATIENT REMAINED NEUROLOGICALLY IMPAIRED THROUGHOUT THE REMAINDER OF THE HOSPITALIZATION. HIS NEUROLOGIC EXAMINATION DEMONSTRATED EVIDENCE OF SEVERE BRAINSTEM DYSFUNCTION. DIAGNOSIS AT TIME OF DEATH WAS ACUTE RIGHT-SIDED INTRAPARENCHYMAL HEMORRHAGE WITH ASSOCIATED BRAIN COMPRESSION. AND RIGHT TO LEFT SHIFT OF INTRACRANIAL CONTENTS WITH EVIDENCE OF RIGHT UNCAL AND DOWNWARD TRANSTENTORIAL HERNIATION. THERE WERE NO REPORTED ALARMS FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO HEMORRHAGIC STROKE. ON (B)(6) 2020, THE PATIENT HAD A TEMPORARY HEMODIALYSIS CATHETER REMOVED DUE TO RENAL RECOVERY AND SUBSEQUENT END OF HEMODIALYSIS TREATMENT. THE SAME DAY, HE WAS SEEN IN THE VAD CLINIC FOR FOLLOW-UP AND RECEIVED A FLU SHOT AND WOUND VACUUM ASSISTED CLOSURE REMOVED FROM RIGHT GROIN. ON (B)(6) 2020, THE PATIENT WENT TO THE EMERGENCY ROOM WITH A FEVER OF MAXIMUM TEMPERATURE 102.3 F PRESENT SINCE (B)(6) 2020. PATIENT HAD BEEN TAKING TYLENOL EVERY 6 HOURS AND HAD BEEN COUGHING UP PHLEGM. IN THE EMERGENCY ROOM, THE PATIENT WAS FOUND TO HAVE ELEVATED INR OF 5.5 AND ELEVATED LACTIC ACID. THE VAD TEAM REWORKED THE ANTICOAGULANT TREATMENT PROTOCOL FOR A LOWER INR GOAL FOR THIS PATIENT OVER THE PREVIOUS MONTH. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPTICEMIA AND SUPRA THERAPEUTIC INR. IN THE EARLY EVENING, THE PATIENT COMPLAINED OF A HEADACHE, THEN LEFT ARM AND LEG NUMBNESS, INABILITY TO STAND, AND THEN SLURRING WORDS. A CT SCAN OF THE PATIENT'S HEAD SHOWED A VERY LARGE RIGHT-SIDED INTRAPARENCHYMAL HEMORRHAGE. THE PATIENT WAS TREATED WITH ANTIEPILETIC THERAPY AND MANNITOL. THE INR WAS REVERSED WITH VITAMIN K, KCENTRA, AND FRESH FROZEN PLASMA. THE PATIENT REMAINED NEUROLOGICALLY IMPAIRED THROUGHOUT THE REMAINDER OF THE HOSPITALIZATION. HIS NEUROLOGIC EXAMINATION DEMONSTRATED EVIDENCE OF SEVERE BRAINSTEM DYSFUNCTION. DIAGNOSIS AT TIME OF DEATH WAS ACUTE RIGHT-SIDED INTRAPARENCHYMAL HEMORRHAGE WITH ASSOCIATED BRAIN COMPRESSION AND RIGHT TO LEFT SHIFT OF INTRACRANIAL CONTENTS WITH EVIDENCE OF RIGHT UNCAL AND DOWNWARD TRANSTENTORIAL HERNIATION. THERE WERE NO REPORTED ALARMS FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179415 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7531137 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| R