BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 12136523 · Received July 8, 2021

    Report

    Report Number
    2916596-2021-03677
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 2, 2021
    Report Date
    September 27, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT SUBMITTED A LOG FILE FOR REVIEW. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINS DATA FROM 12MAY2021 AT 22:49:23 THROUGH 02JUN2021 AT 7:56:54 AND 28MAY2021 AT 4:52:28 THROUGH 08JUN2021 AT 14:53:40. THE LOG FILE WAS COMPRISED OF ROUTINE POWER CABLE DISCONNECTS AND PI EVENTS. TRANSIENT PI EVENTS WERE OBSERVED THROUGHOUT THE LOG FILE, RESULTING IN MOMENTARY DECREASES IN SPEED PER DESIGN. THE PUMP APPEARED TO FUNCTION AS INTENDED THE ACCOUNT COMMUNICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A HEART FAILURE EXACERBATION. COUMADIN WAS PLACED ON HOLD AND THE PATIENT RECEIVED OUTFLOW GRAFT STENTING FOR OUTFLOW GRAFT OBSTRUCTION FOR A THROMBUS ON (B)(6) 2021. THE PATIENT WAS GIVEN CONTINUOUS IV HEPARIN AND COUMADIN WAS RESUMED ON (B)(6) 2021. THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO SUBTHERAPEUTIC INR AND COUMADIN DOSAGES WERE BOOSTED AND HEPARIN CONTINUED. ACCORDING TO THE ACCOUNT, THE PATIENT WAS DISCHARGED TO HOME AND WAS INSTRUCTED TO TAKE LOVENOX IN ADDITION TO COUMADIN TO REACH A THERAPEUTIC INR LEVEL. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). THE HEARTMATE 3 LVAS IFU, REV. C, IS CURRENTLY AVAILABLE. SECTION 1 LIST LISTS DEVICE THROMBUS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION AND PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-003463 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-03678.

    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

    WHILE THE PATIENT IS CURRENTLY ADMITTED TO THE HOSPITAL FOR A HEART FAILURE EXACERBATION. THE PATIENT RECEIVED OUTFLOW GRAFT STENTING FOR OUTFLOW GRAFT OBSTRUCTION FOR A THROMBUS ON (B)(6) 2021. COUMADIN WAS PLACED ON HOLD IN PREPARATION FOR THE STENTING. INTERNATIONAL NORMALIZED RATIO (INR) BECAME SUBTHERAPEUTIC AND PATIENT WAS GIVEN CONTINUOUS IV HEPARIN. COUMADIN WAS RESUMED ON (B)(6) 2021. PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO SUBTHERAPEUTIC INR. COUMADIN DOSAGES WERE BOOSTED, AND HEPARIN CONTINUED. INR ROSE TO 1.7 ON (B)(6) 2021. PATIENT WAS DISCHARGED TO HOME AND WAS INSTRUCTED TO TAKE LOVENOX IN ADDITION TO COUMADIN TO REACH A THERAPEUTIC INR LEVEL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036305 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R