BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13933525 · Received March 28, 2022

    Report

    Report Number
    2916596-2022-01168
    Event Type
    Death
    Date Received
    March 28, 2022
    Date of Event
    February 13, 2022
    Report Date
    May 11, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE: MULTIPLE ORGAN DYSFUNCTION SYNDROME. MAIN INVESTIGATION CONCLUSION. A SPECIFIC CAUSE FOR THE REPORTED EVENTS, AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2021. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, INFECTION (LOCAL, DRIVELINE, PUMP POCKET), SEPSIS, MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, AND HEPATIC DYSFUNCTION), VENOUS THROMBOEMBOLISM, PERICARDIAL FLUID COLLECTION, WOUND DEHISCENCE, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS ARRHYTHMIA, INFECTION, AND THROMBOEMBOLISM AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS. SECTION 5, "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿), INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. FURTHERMORE, SECTION 5, UNDER ¿IMPLANT PROCEDURES¿, WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 OF THE IFU, UNDER ¿ANTICOAGULATION¿, PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU, UNDER ¿RIGHT HEART FAILURE, STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. ADDITIONALLY, SECTION 6, UNDER ¿CAUTION!¿, EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP. FURTHERMORE, SEVERAL SECTIONS OF THE HEARTMATE 3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF 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 HAD BEEN HAVING PROGRESSIVE ACUTE KIDNEY INJURY (AKI) FOR AT LEAST 48 HOURS. THE PATIENT BECAME OLIGOANURIC. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED ON (B)(6) 2022. THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN WITH THEIR LOWEST RECORDED LEVEL BEING 6.7 GRAMS PER DECILITRE (G/DL). A CHEST X-RAY REVEALED A SMALL BILATERAL PERICARDIAL EFFUSION. THE PATIENT DISPLAYED EVIDENCE OF CARDIOGENIC SHOCK AND RIGHT HEART FAILURE THAT REQUIRED INOTROPES AND VASOPRESSORS. ON (B)(6) 2022 AN ULTRASOUND REVEALED BILATERAL INTERNAL JUGULAR VENOUS THROMBOEMBOLISMS. THEIR NECK IVS WERE DISCONTINUED. ON (B)(6) 2022 THE PATIENT HAD A POTENTIAL POST-OPERATIVE INFECTION. NO GROWTH WAS NOTED IN THE CULTURES. THE PATIENT WAS STARTED ON ANTIBIOTICS. AN ECHOCARDIOGRAM WAS PERFORMED ON (B)(6) 2022 THAT REVEALED ATRIAL FIBRILLATION. ALSO ON (B)(6) 2022 THE PATIENT HAD STERNAL WOUND DEHISCENCE. THEY WERE BROUGHT BACK TO THE OPERATING ROOM (OR) FOR MEDIASTINAL EXPLORATION. THE WOUND WAS PACKED AND LEFT OPEN. THE PATIENT EXPIRED ON (B)(6) 2022 DUE TO RIGHT HEART FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT HAD AN ACUTE KIDNEY INJURY (AKI) ON CHRONIC KIDNEY DISEASE (CKD) 3. THE PATIENT HAD A HISTORICAL BASELINE CREATININE LEVEL OF 1.7-2, HOWEVER, CREATININE VALUES PEAKED AT 6.55 AT THIS TIME AND POTASSIUM WAS MARGINALLY ELEVATED. THE PATIENT REPORTEDLY HAD THE AKI LASTING AT LEAST 48 HOURS AND BECAME OLIGOANURIC. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED ON (B)(6) 2022. THE RENAL DYSFUNCTION WAS NOT THOUGHT TO BE DEVICE RELATED AS THE PATIENT HAD EXPERIENCED RENAL DYSFUNCTION PRIOR TO THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IMPLANT. ON (B)(6) 2022, THE PATIENT HAD A PROGRESSIVE DROP IN HEMOGLOBIN WITH THE LOWEST VALUE RECORDED AT 6.7 G/DL. DUE TO HOSPITAL POLICY, THE CAUSE FOR THE DROP IN HEMOGLOBIN AS WELL AS INFORMATION ON ANY TREATMENT FOR THE CONDITION WAS UNABLE TO BE PROVIDED. ON (B)(6) 2022, A CHEST X-RAY REVEALED A SMALL BILATERAL PERICARDIAL EFFUSION. NO TREATMENT WAS PROVIDED, AND THE EVENT REPORTEDLY RESOLVED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAD ONGOING EVIDENCE OF CARDIOGENIC SHOCK REQUIRING INOTROPES AND VASOPRESSORS. THE PATIENT WAS STARTED ON PROLONGED DOBUTAMINE FOR RIGHT VENTRICULAR (RV) DYSFUNCTION. ON (B)(6) 2022, AN ULTRASOUND WAS PERFORMED WHICH REVEALED BILATERAL INTERNAL JUGULAR VENOUS THROMBOEMBOLISMS (VTES). THE PATIENT¿S NECK LINES WERE DISCONTINUED, AND NO OTHER TREATMENT WAS REPORTEDLY PROVIDED. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE ATRIAL FIBRILLATION ON AN ELECTROCARDIOGRAM (ECD). NO TREATMENT WAS GIVEN AND DUE TO HOSPITAL POLICY, INFORMATION REGARDING THE PATIENT¿S HISTORY OF ARRHYTHMIA WAS UNABLE TO BE PROVIDED. ON THE SAME DAY, STERNAL DEHISCENCE WAS NOTED ON A COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) FOR A MEDIASTINAL EXPLORATION. THE WOUND WAS PACKED AND LEFT OPEN. CULTURES TAKEN REVEALED NO GROWTH; HOWEVER, THE PATIENT WAS STARTED ON ANTIBIOTICS ON (B)(6) 2022 FOR A POTENTIAL POST-OPERATIVE INFECTION. THE TYPE OF INFECTION WAS UNABLE TO BE PROVIDED. THE ACCOUNT LATER REPORTED THAT THE PATIENT RETURNED TO THE OR FOR POSSIBLE SEPSIS AND VENTILATORY SUPPORT WAS REQUIRED FOR ACUTE RESPIRATORY FAILURE. THE PATIENT¿S FAMILY MADE THE DECISION TO WITHDRAW SUPPORT AND THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2022, DUE TO RIGHT HEART FAILURE. DUE TO HOSPITAL POLICY, NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. IT WAS REPORTED THAT THE DEVICE WAS NOT EXPLANTED AND WOULD NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24858 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 8176443 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death| H| R