BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 13099317 · Received December 28, 2021

    Report

    Report Number
    2916596-2021-07356
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    December 3, 2021
    Report Date
    January 24, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS (INFECTION, SHORTNESS OF BREATH, AND CHEST PAIN), AS WELL AS A DIRECT CORRELATION TO HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED PI (PULSATILITY INDEX) EVENTS; HOWEVER, A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED DATA FROM 08:18:10 THROUGH 14:58:56 ON (B)(6) 2021, PER THE TIMESTAMPS. THE ENTIRE LOG FILE CONSISTED OF PI EVENTS. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AND OPERATED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6) WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C IS CURRENTLY AVAILABLE. SECTION 1 LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THE IFU ALSO OUTLINES CARE INSTRUCTIONS IN REFERENCE TO PREVENTING INFECTION, INCLUDING EXIT SITE TREATMENT. SECTION 4 STATES THAT PULSATILITY INDEX (PI) EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS, AND 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. THESE TYPES OF PI EVENTS ARE MORE LIKELY TO BE TRIGGERED IN CASES OF LOW PULSATILITY. SECTION 6 EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR SHORTNESS OF BREATH AND CHEST PAIN ON (B)(6) 2021. THE NURSE NOTICED A SPEED DROP ON THE PATIENTS CONTROLLER DOWN TO 8100 ROTATIONS PER MINUTE (RPM) BUT NOT BELOW THE LOW SPEED LIMIT OF 8000 RPM. THE CONTROLLERS SET SPEED WAS 9600 RPM. THE WERE NO CONTROLLER ALARMS OR LOW FLOWS. THE PATIENT REPORTED AN INCIDENT OF DROPPING BATTERIES A WEEK PRIOR WHICH PULLED THE DRIVELINE. THERE WAS TENDERNESS TO PALPATION ALONG THE DRIVELINE TRACT. THE PATIENT WAS TO BE DISCHARGED AND ANTIBIOTICS WERE ORDERED. THE LOG FILE CAPTURED 240 PULSATILITY INDEX (PI) EVENTS THAT OCCURRED ON (B)(6) 2021 AT 8:18AM -2:58 PM. THE LOG DID NOT DISPLAY ANY LOW SPEED EVENTS BELOW THE LOW SET LIMIT PF 8000 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998957 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 7564245 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H