BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10441945 · Received August 24, 2020

    Report

    Report Number
    2916596-2020-03890
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    July 16, 2020
    Report Date
    October 29, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT¿S DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-011149, AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE LOG FILES PROVIDED BY THE ACCOUNT DID NOT CONTAIN ANY RELEVANT DATA FROM THE EVENT DATE OF (B)(6) 2020; HOWEVER, THE FILES CAPTURED THE PUMP FUNCTIONING AS INTENDED. THE PATIENT WAS LATER DISCHARGED AND REMAINED ONGOING ON VAD SUPPORT UNTIL THEY EXPERIENCED FURTHER INFECTION RELATED ISSUES IN (B)(6) 2020 (RELATED MANUFACTURER REPORT NUMBER: 2916596-2020-05085). INCIDENTAL FINDINGS: REVIEW OF THE LOG FILES PROVIDED BY THE ACCOUNT REVEALED PERSISTENT DCLINK EVENTS ASSOCIATED WITH LOCKED LVAD MONITOR CURRENT VALUES AT 440 MA. THE DCLINK EVENTS DID NOT RESULT IN ANY LVAD FAULTS OR AUDIBLE ALARMS. BASED ON PREVIOUS COMPLAINT HISTORY, THESE FINDINGS APPEARED TO BE INDICATIVE OF AN ISSUE WITH THE CURRENT MONITORING CIRCUIT BOARD ON THE PUMP; HOWEVER, A SPECIFIC ROOT CAUSE OF THIS CURRENT MONITORING ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-011149 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2018. THE HM 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE HM3 IFU AND PATIENT HANDBOOK INSTRUCT THE PATIENT TO ¿STABILIZE THE DRIVELINE AT ALL TIMES TO AVOID PULLING ON OR MOVING THE DRIVELINE AT THE EXIT SITE¿. THESE DOCUMENTS FURTHER WARN THAT ¿PULLING ON OR MOVING THE DRIVELINE CAN KEEP THE EXIT SITE FROM HEALING OR DAMAGE AN ALREADY HEALED EXIT SITE. EXIT SITE TRAUMA OR TISSUE DAMAGE CAN INCREASE THE PATIENT¿S RISK OF GETTING A SERIOUS INFECTION.¿ FURTHERMORE, THE HM3 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.

    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 WAS READMITTED ON (B)(6) 2020 DUE TO SUSPECTED DRIVELINE INFECTION. THERE WERE SYMPTOMS OF REDNESS, PAIN, AND DISCHARGE FROM THE DRIVELINE EXIT SITE. THE PATIENT HAS DYSPNEA DURING ACTIVITY. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED NORMAL LEFT VENTRICLE SIZE BUT SEVER SYSTOLIC DYSFUNCTION. THERE WAS NO EVIDENCE OF OBSTRUCTION. THE SEPTUM WAS OBSERVED IN MIDLINE AND WAS NOT SHIFTING. CULTURES FROM SMEAR OF DRIVELINE SECRETION WERE NEGATIVE. LOG FILES WERE EXTRACTED AND THE PUMP SPEED WAS INCREASED FROM 5600 RPM TO 5800 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905698 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6453924

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R