BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23011829 · Received September 9, 2025

    Report

    Report Number
    2916596-2025-05524
    Event Type
    Death
    Date Received
    September 9, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 ADDITIONAL CODE: 4642 - ADDITIONAL DEVICE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW HAZARD ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THE ALARMS COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILES CONTAINED EVENTS FROM THE TIMESTAMPS OF 14AUG2020 AND 14AUG2025. THROUGHOUT THE ENTIRETY OF THE FILE ESTIMATED FLOW RANGED FROM 0.4-2.0 LITERS PER MINUTE (LPM), WHICH RESULTED IN A CONTINUOUS LOW FLOW HAZARD ALARM. OF NOTE, THE PULSATILITY INDEX (PI) VALUES GREATLY VARIED, RANGING FROM 3.0-14.3 DURING THESE LOW FLOW EVENTS. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED DESPITE THE DECREASE IN FLOW. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION, BLEEDING, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO ADDRESSES PUMP PARAMETERS, INCLUDING PUMP FLOW, SECTION 4 OF THE IFU, ¿HEARTMATE TOUCH COMMUNICATION SYSTEM¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THIS SECTION ALSO OUTLINES SITUATIONS THAT CAN RESULT IN A LOW FLOW ALARM AND FURTHER EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING," AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿ OUTLINE SYSTEM CONTROLLER ALARMS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION H6: INVESTIGATION CONCLUSIONS CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A NON-ROUTINE POST-OPERATIVE COURSE. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG), REVERSE SAPHENOUS VEIN GRAFT TO PATENT DUCTUS ARTERIOSUS (RGSV-PDA), INSERTION OF IMPELLA RP VIA RIGHT COMMON FEMORAL VEIN (CFV), AND LEFT ATRIAL APPENDAGE LIGATION (LAAL) WITH A 45 MM ATRICLIP. INTRA-AORTIC BALLOON PUMP (IABP) WAS REMOVED ON (B)(6) 2025. THE PATIENT WAS INTUBATED AND SEDATED WITH FIO2 AT 60% AND POSITIVE END EXPIRATORY PRESSURE (PEEP) AT 5. CENTRAL VENOUS PRESSURE (CVP) WAS 9 TO 10 MMHG, PULMONARY ARTERY (PA) PRESSURES WERE 16/12/14 MMHG, CARDIAC OUTPUT (CO) WAS 2.3 LITERS PER MINUTE (LPM), AND CARDIAC INDEX (CI) WAS 1.3 LPM/M2. MIXED VENOUS OXYGEN SATURATION (SVO) WAS 50%. THE IMPELLA RP WAS SET TO P9 WITH A FLOW OF 3.6 LPM. VASOACTIVE SUPPORT INCLUDED EPINEPHRINE AT 0.07 G/KG/MIN, VASOPRESSIN AT 0.04 UNITS/MIN, AND MILRINONE AT 0.25 G/KG/MIN. THE PUMP SPEED WAS AT 4900 REVOLUTIONS PER MINUTE (RPM), WITH LOW FLOW ALARMS IN THE SETTING OF LOW MEAN ARTERIAL PRESSURES (MAPS). THE PATIENT WAS HEMODYNAMICALLY UNSTABLE. PACKED RED BLOOD CELLS (PRBCS) WERE ACTIVELY BEING TRANSFUSED DUE TO EXCESSIVE BLEEDING. A MEDIASTINAL RE-EXPLORATION WAS PERFORMED, DURING WHICH NO BLEEDING WAS FOUND. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO COMPUTED TOMOGRAPHY (CT) IN CRITICAL CONDITION, WHERE ACTIVE EXTRAVASATION FROM THE RIGHT INFERIOR EPIGASTRIC ARTERY WAS DETECTED. THE PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION. THE PLAN OF CARE INCLUDED A GUARDED PROGNOSIS, WITH INSTRUCTIONS TO WEAN EPINEPHRINE AS TOLERATED, CONTINUE MILRINONE 0.25, CONTINUE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), AND WEAN VENTILATOR SUPPORT AS ABLE. FOLLOWING REVIEW, LOG FILES CAPTURED APPROXIMATELY FIVE HOURS OF DATA, PRIMARILY DUE TO PERSISTENT LOW FLOW EVENTS. DESPITE A FIXED SPEED OF 4700 RPM, ESTIMATED FLOWS REMAINED CONSISTENTLY BELOW 1 LPM. PULSATILITY INDEX (PI) VALUES WERE NOTED TO BE WIDELY VARIABLE. ADDITIONALLY, ON (B)(6) 2025, THE SITE REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS MULTI SYSTEM ORGAN FAILURE (MSOF). THE PATIENT'S SPOUSE TRANSITIONED THE PATIENT TO DO NOT INTUBATE (DNI) AND DO NOT RESUSCITATE (DNR) COMFORT MEASURES ONLY (CMO). THE DEATH WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868725 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00002429

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death