BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 18220542 · Received November 28, 2023

    Report

    Report Number
    2916596-2023-08137
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    November 14, 2023
    Report Date
    June 4, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED; SECTION D4 CATALOG NUMBER: CORRECTED; SECTION D4 PRIMARY UDI NUMBER: CORRECTED; NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION FINDINGS - 4251 - UNDESIRABLE PRESENCE OF ENDOGENOUS MATERIALS. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF COMPRESSION BETWEEN THE OUTFLOW GRAFT (OFG) BEND RELIEF AND OFG CANNOT BE CONFIRMED THROUGH THIS EVALUATION AS NO IMAGES WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE. ADDITIONALLY, THE REPORTED LOW FLOW ALARMS WERE CONFIRMED THROUGH REVIEW OF THE SUBMITTED LOG FILES; HOWEVER, A SPECIFIC CAUSE FOR THE REPORTED ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILES REVEALED MULTIPLE LOW FLOW ALARMS BEFORE AND AFTER THE DATE OF THE REPORTED OFG OPERATION. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. 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) REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK REV. D ARE CURRENTLY AVAILABLE. SECTION 4, ¿SYSTEM MONITOR,¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM OCCURS WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM). A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," 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. SECTION 5, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH.". SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ EXPLAINS SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, ALSO OUTLINES SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. 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 WAS ADMITTED TO THE HOSPITAL WITH LOW FLOW ALARMS AND LESS OFFLOADING OF THE LEFT VENTRICLE. A RAMP STUDY WAS PERFORMED, AND THE ATRIOVENTRICULAR VALVE CONTINUED TO OPEN WITH EVERY BEAT BUT WAS UNABLE TO UNLOAD THE LEFT VENTRICLE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED TO DETERMINE WHETHER THE PATIENT HAD OUTFLOW GRAFT (OFG) THROMBUS OR COMPRESSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND FOUND TO HAVE OFG COMPRESSION BETWEEN THE OFG BEND RELIEF AND OFG. THE BEND RELIEF WAS REMOVED AND FIBIN SUBSTANCE WAS REMOVED FROM AROUND THE OFG, WHICH IMPROVED FLOW. THERE WERE NO CHANGED TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE OFG OBSTRUCTION. THE PUMP SPEED WAS INCREASED INCREMENTALLY FROM 5200 ROTATIONS PER MINUTE (RPM) TO 6000 RPM TO ASSIST WITH OFFLOADING THE LEFT VENTRICLE. THE PATIENT WAS SENT TO THE ICU FOR RECOVERY BUT THEY WERE STILL HAVING INTERMITTENT LOW FLOW ALARMS. THE LOW FLOW ALARMS OCCURRED MOSTLY WITH ACTIVITIES. THE EVENT LOG FILES CAPTURED LOW FLOW EVENTS ON 15NOV2023, SOME OF WHICH WERE TOO BRIEF TO TRIGGER THE ALARM. THE LOW FLOW EVENTS OCCURRED WHILE PULSATILITY INDEX (PI) WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537701 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6876947 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R