BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24283190 · Received February 6, 2026

    Report

    Report Number
    2916596-2026-00606
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 17, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067039323
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 - PATIENT WEIGHT NOT PROVIDED. 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: THE REPORTED OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION; HOWEVER, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED MULTIPLE LOW FLOW ALARMS. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 22JAN2026, PER THE TIMESTAMPS. INTERMITTENT LOW FLOW HAZARD ALARMS WERE CAPTURED THROUGHOUT THE FILE. ADDITIONALLY, THE SYSTEM CONTROLLER PERIODIC LOG FILE CAPTURED MULTIPLE LOW FLOW ALARMS BETWEEN 12JAN2026 AND 22JAN2026. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP OPERATED AT THE SET SPEED FOR THE ENTIRETY OF THE FILES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. CHAPTER 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. CHAPTER 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. CHAPTER 5 OF THE IFU, ¿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. CHAPTER 5 ALSO CONTAINS A SUB-CHAPTER 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. THIS CHAPTER ALSO INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW 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. CHAPTER 5 OF THE IFU, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS CHAPTER ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF. THE HEARTMATE 3 LVAS ALARMS FOR PATIENTS AND THEIR CAREGIVERS AND CLINICIANS EXPLAIN THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.0 LITERS PER MINUTE (LPM). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OUTFLOW GRAFT OBSTRUCTION (OGO). THE PATIENT EXPERIENCED LOW FLOW ALARMS THAT WERE ONLY RELIEVED WHEN THEY LAY COMPLETELY FLAT BUT RESUMED WITH ANY POSITION CHANGES SUCH AS SITTING UP AND STANDING. RIGHT VENTRICULAR FAILURE AS WELL AS HYPER/HYPO WERE ELIMINATED FROM DIFFERENTIAL. RESULTS FOR A COMPUTED TOMOGRAPHIC ANGIOGRAPHY WERE PENDING, AND TRANSTHORACIC ECHOCARDIOGRAM RESULTS WERE WAITING TO BE READ. THE LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILES CAPTURED MULTIPLE LOW FLOW EVENTS ON 22JAN2026 AND CONTAINED LOW FLOW ESTIMATES AS WELL AS SUSTAINED LOW FLOW HAZARD EVENTS WHEN THE CALCULATED PULSATILITY INDEX (PI) WAS DYNAMIC AND ELEVATED. IT WAS LATER COMMUNICATED THAT THE PATIENT WAS EXPLANTED ON (B)(6) 2026. THE OUTCOME WAS CONSIDERED DEVICE OR THERAPY RELATED. THE DEVICE PARAMETERS WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544634 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00003793 05415067039323

    Patients

    Seq Age Sex Outcome Treatment
    1