BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP

    MDR report key: 11058691 · Received December 22, 2020

    Report

    Report Number
    2916596-2020-06249
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    December 4, 2020
    Report Date
    November 2, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER PI-2022-0042879-03, MFR# 2916596-2022-02063 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 26SEP2022, THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE CAUSE OF THESE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT SHOULD BE NOTED THAT THE PATIENT HAD A COMPLAINT OF A STRANGE NOISE COMING FROM THE PUMP OCCURRING IN (B)(6) 2021 (REFERENCE MFR# 2916596-2021-00505). THE ACCOUNT INDICATED THAT A CAUSE FOR THE NOISE COULD NOT BE IDENTIFIED. THE PATIENT REMAINED ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), UNTIL UNDERGOING PUMP EXCHANGE IN (B)(6) 2021 DUE TO SUSPECTED PUMP THROMBOSIS (REFERENCE MFR# 2916596-2021-01187). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 22JUN2015. THE HEARTMATE II (HM II) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND HM II PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 5 OF THE IFU LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. SECTION 13 OF THE THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING EACH OF THE PUMP PARAMETERS, INCLUDING PUMP POWER. SECTION 13.3.2 "LOW SPEED LIMIT" PROVIDES AN EXPLANATION OF PI (SUCTION) EVENTS. SECTION 17.1 "UNIQUE TREATMENT ISSUES" EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTION 17.4 "ANTICOAGULATION THERAPY" OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN FOR PATIENTS USING THE HEARTMATE II LVAS. ADDITIONALLY, THE HMII PATIENT HANDBOOK CAUTIONS THAT THE APPROPRIATE PERSONNEL SHOULD BE NOTIFIED IF THERE IS A CHANGE IN HOW THE PUMP WORKS, SOUNDS, OR FEELS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF "IRREGULAR VIBRATIONS" COMING FROM THE PUMP COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. FURTHERMORE, A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE CAUSE OF THESE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2020 AFTER FEELING "IRREGULAR VIBRATIONS" COMING FROM THE PUMP. THE PATIENT¿S LDH LEVEL WAS AT 930 AND SURGEONS WERE CONSIDERING PUMP EXCHANGE. THE PATIENT WAS ASYMPTOMATIC. IT WAS DECIDED NOT TO PERFORM A PUMP EXCHANGE, AND IT WAS NOTED THAT THE PATIENT WAS WAITING FOR DISCHARGE SOON. REVIEW OF THE SUBMITTED LOG FILE APPEARED TO SHOW THE PUMP OPERATING AS INTENDED. THE PATIENT WAS ULTIMATELY EXCHANGED TO HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), ON (B)(6) 2021 (SEE RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-01187). 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 II (HM II) LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (LVAS IFU) AND HM II PATIENT HANDBOOK IS CURRENTLY AVAILABLE. DEVICE THROMBOSIS IS LISTED AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. THE HMII LVAS IFU CONTAINS INFORMATION REGARDING PUMP SPEED, POWER, FLOW, AND PI. THE IFU EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU DISCUSSES ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE HMII PATIENT HANDBOOK CAUTIONS THAT THE APPROPRIATE PERSONNEL SHOULD BE NOTIFIED IF THERE IS A CHANGE IN HOW THE PUMP WORKS, SOUNDS, OR FEELS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE PATIENT EXPERIENCED HEMOLYSIS AND WAS READMITTED FROM (B)(6) 2020 TO (B)(6) 2020. LDH VALUE WAS 903IU/L, HEMATOCRIT WAS 30%, AND HYPERBILIRUBINEMIA WAS NOT OBSERVED. CARDIAC CATHETERIZATION WAS PERFORMED AND DETECTED THE FOLLOWING: CENTRAL VENOUS PRESSURE (CVP) OF 4 MMHG, PULMONARY ARTERY (PA) SYSTOLIC BLOOD PRESSURE OF 23MMHG, PA DIASTOLIC BLOOD PRESSURE OF 12MMHG, PULMONARY CAPILLARY WEDGE PRESSURE (PCW) OF 6MMHG, AND CARDIAC OUTPUT OF 4.1L/MIN. THE HEMOLYSIS WAS THOUGHT TO BE RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD BEEN ADMITTED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    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 VISITED THE OUTPATIENT CLINIC FOR IRREGULAR VIBRATIONS COMING FROM THE PUMP. THE PATIENT HAD AN ELEVATED LDH (LACTATE DEHYDROGENASE). THE PATIENT HAD NO OTHER SYMPTOMS. THE SITE WAS CONSIDERING A PUMP EXCHANGE, BUT ULTIMATELY DECIDED NOT TO. A LOG FILE WAS SENT IN FOR REVIEW WHICH FOUND FLOWS ABOVE NORMAL PARAMETERS. THE PLAN OF CARE WAS TO MONITOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519786 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104911JPN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R