BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 17776921 · Received September 19, 2023

    Report

    Report Number
    2916596-2023-06498
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 28, 2023
    Report Date
    December 12, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, AN ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED THE REPORT OF MULTIPLE PULSATILITY INDEX (PI) EVENTS; HOWEVER, A SPECIFIC CAUSE FOR THE PI EVENTS COULD NOT BE DETERMINED. THE SUBMITTED LOG FILES COLLECTIVELY CONTAINED EVENTS FROM 27AUG2023 THOUGH 31AUG2023. THE FILE CAPTURED MULTIPLE PI EVENTS THROUGHOUT THE DURATION OF THE FILES. NO OTHER NOTABLE EVENTS OR ALARMS ASSOCIATED WITH THE PUMP WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED FOR THE DURATION OF THE FILE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS WERE SENT TO THE ACCOUNT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINED ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), UNTIL ULTIMATELY EXPIRING ON 03OCT2023 (MFR # 2916596-2023-06944). NO PRODUCT WAS RETURNED FOR 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 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING BLEEDING, HEMOLYSIS, AND RENAL FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 OF THIS IFU ALSO ADDRESSES ALL PUMP PARAMETERS INCLUDING PULSATILITY INDEX (PI). SECTION 4, ¿SYSTEM MONITOR¿, STATES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU ALSO STATES THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MM HG SHOULD BE CONSIDERED ADEQUATE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT FOR A CLINIC VISIT AND HAD AN ECHOCARDIOGRAM DONE. THE PATIENT HAD WEIGHT GAIN, ELEVATED CREATININE LEVEL OF 2.81MG/DL, HEMOGLOBIN VALUE OF 6.8 G/DL, LOW PLATELET COUNT (41), MEAN ARTERIAL PRESSURE (MAP) OF 98 MMHG, AND AN INTERNAL NORMALIZED RATIO (INR) OF 2.6. THE PATIENT HAD AN ELEVATED LACTATE DEHYDROGENASE (LDH) OF 338U/L AND A LARGE HEMATOMA ON THEIR LEG DUE TO HITTING IT ON A CHAIR. THERE WAS NO BLOOD IN THEIR STOOL AND NO DIZZINESS OR LIGHTHEADEDNESS. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY VENTRICULAR ASSIST DEVICE (VAD) ALARMS AT HOME. ON INTERROGATION MULTIPLE PULSATILITY INDEX (PI) EVENTS WERE SEEN WITH A RANGE OF 2-6.2 OVER THE PREVIOUS 2 DAYS. POWER WAS NOTED TO BE 6.7 W, FLOW WAS 6.2 LPM, PI WAS 3.4 AT THE TIME, AND SPEED WAS 9600 RPM. THE DRIVELINE SITE WAS NOTED TO BE CLEAN, DRY, AND INTACT. A REVIEW OF THE LOG FILES CAPTURED SOME PERIODS OF PI EVENTS FROM (B)(6) 2023. NO OTHER UNUSUAL EVENTS WERE SEEN IN THE LOG. IT WAS FURTHER NOTED THAT THE PATIENT REFUSED AN INCREASED BLOOD PRESSURE MEDICATION, AS WELL AS ADMISSION FOR ANY TYPE OF PROCEDURES OR INFUSIONS. THE PATIENT WOULD RECEIVE 2 UNITS OF BLOOD ON (B)(6) 2023 AT 0630. ON (B)(6)2023, THE PATIENT WAS ADMITTED FOR ANEMIA AND POSSIBLE BONE MARROW BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998182 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 6706671 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| L| R