BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22216510 · Received June 16, 2025

    Report

    Report Number
    2916596-2025-03659
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 23, 2025
    Report Date
    May 6, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    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: THE REPORT OF AN OUTFLOW GRAFT OBSTRUCTION WAS UNABLE TO BE CONFIRMED AS NO PRODUCT OR IMAGES WERE SUBMITTED FOR EVALUATION, AND A SPECIFIC CAUSE FOR THE REPORTED OBSTRUCTION COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED A TRANSIENT LOW FLOW ALARM; HOWEVER, A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED INTERMITTENT LOW FLOW EVENTS WITH A TRANSIENT LOW FLOW ALARM ON (B)(6) 2025. THE LOW FLOW ALARM THRESHOLD WAS SET TO 2.0 LITERS PER MINUTE (LPM) PER A PREVIOUS CONTROLLER SOFTWARE UPDATE UNDER CS-142752. ELEVATED PULSATILITY INDEX (PI) VALUES WERE ALSO NOTED DURING THE LOW FLOW EVENTS. THE SYSTEM APPEARED TO BE OPERATING AS INTENDED AT THE SET SPEED, AND THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILES. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE PATIENT REMAINS ONGOING ON (B)(6). 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 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING FLOW, POWER, AND PULSATILITY INDEX (PI). THIS SECTION EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 1 EXPLAINS THAT IN GENERAL, THE MAGNITUDE OF THE PI VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (IE, THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). LOWER VALUES INDICATE LESS VENTRICULAR FILLING AND LOWER PULSATILITY (IE, THE PUMP IS PROVIDING GREATER SUPPORT AND FURTHER UNLOADING THE VENTRICLE). SECTION 4 ¿HEARTMATE TOUCH COMMUNICATION SYSTEM¿ STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM (LITERS PER MINUTE) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. SECTION 5 "SURGICAL PROCEDURES" CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5 INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS SECTION WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. THE HM3 (HEARTMATE 3) LVAS POCKET GUIDES TO ALARMS FOR PATIENTS AND CLINICIANS EXPLAIN THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.0 LPM. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 HAD A KNOWN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). THE PATIENT HAD A FEW LOW FLOW ALARMS WITH NO SYMPTOMS NOTED. LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG DISPLAYED LOW FLOW AS MENTIONED WHICH SEEMED TO BE PHYSIOLOGICAL IN NATURE WHERE THE LOW FLOW ESTIMATOR DROPPED BELOW 2.0 LITERS PER MINUTE (LPM) (INCLUDING MULTIPLE LOW FLOW FLAGS - LOWER FLOWS NOT SUSTAINED LONG ENOUGH (AT LEAST 10 SECONDS) TO ACTIVATE THE AUDIBLE ALARM). THESE OCCURRED AT TIMES WHEN PULSATILITY INDEX (PI) WAS ELEVATED. THERE DID NOT APPEAR TO BE ANY TYPE OF MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT ISSUES CAUSING THESE EVENTS. THE LOW FLOW EVENTS SEEMED TO BE A PATIENT RELATED ISSUE AND NOT AN EQUIPMENT RELATED ISSUE. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILES. THE MCS EQUIPMENT APPEARED TO HAVE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438783 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6476692 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention