BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20336425 · Received September 30, 2024

    Report

    Report Number
    2916596-2024-06159
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 9, 2024
    Report Date
    November 22, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION H6: HEALTH EFFECT-IMPACT AND MEDICAL DEVICE PROBLEM CODES, UPDATED. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT OBSTRUCTION WAS UNABLE TO BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE. FURTHERMORE, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED PULSATILITY INDEX (PI) EVENTS, HOWEVER THE REPORTED LOW FLOW ALARM WAS UNABLE TO BE CONFIRMED. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 26AUG2024 ¿ 09SEP2024. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO BE OPERATING AS INTENDED AT THE STORED PATIENT SPEED. THE ACCOUNT SUBMITTED AN ADDITIONAL SET OF LOG FILES ON (B)(6)2024 FOLLOWING THE OUTFLOW GRAFT REPAIR PROCEDURE ON (B)(6) 2024. THE SUBMITTED CONTROLLER EVENT LOG FILE CONTAINED EVENTS ON 08OCT2024, THE MAJORITY OF WHICH WERE PI EVENTS. SEVERAL PI EVENTS WERE ALSO CAPTURED THROUGHOUT THE SUBMITTED CONTROLLER PERIODIC LOG FILE, WHICH CONTAINED DATA FROM (B)(6) 2024. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED IN THE LOG FILES, AND THE PUMP APPEARED TO BE OPERATING AS INTENDED AT THE STORED PATIENT SPEED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), WITH NO FURTHER RELATED EVENTS REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. THE IFU 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 DOCUMENT CAUTIONS THE USER THAT THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT, SURGICAL ELEMENT, OR BODY STRUCTURE. ADDITIONALLY, THE IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS DOCUMENT ALSO NOTES THAT, IN GENERAL, THE MAGNITUDE OF THE PULSATILITY INDEX (PI) VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (I.E., THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). THE IFU ALSO EXPLAINS THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS, INCLUDING SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM (REVOLUTIONS PER MINUTE) PER SECOND TO THE FIXED SPEED SETPOINT. THE IFU AND THE PATIENT HANDBOOK ALSO DESCRIBE ALARM CONDITIONS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. 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) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING PUMP FLOW, SPEED, AND PULSATILITY INDEX. THIS SECTION EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER, AND PULSATILITY INDEX (PI) EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM (REVOLUTIONS PER MINUTE) PER SECOND TO THE FIXED SPEED SETPOINT. IT IS ALSO NOTED THAT THE SYSTEM MONITOR DISPLAYS THE PUMP SPEED IN REVOLUTIONS PER MINUTE. THIS VALUE MATCHES THE ACTUAL SPEED WITHIN ±100 RPM UNDER NOMINAL CONDITIONS. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS SECTION ALSO NOTES THAT, IN GENERAL, THE MAGNITUDE OF THE PULSATILITY INDEX (PI) VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (I.E., THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). 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 OF THE IFU, 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 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING" OUTLINE SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THESE DOCUMENTS INSTRUCT THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    B5, ADDITIONAL INFORMATION E4; MEDWATCH #2201100000-2024-8021. H6: HEALTH EFFECT CLINICAL CODE, IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, UPDATED NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS AT THE HOSPITAL FOR A WORKUP OF AN OUTFLOW GRAFT OBSTRUCTION (OGO). NO VENTRICULAR ASSIST DEVICE (VAD) ALARMS WERE IN THE INTERROGATION, BUT FLOWS WERE LOWER THAN THE PATIENT'S BASELINE. LOG FILES WERE SENT FOR REVIEW. IT WAS NOTED THAT THE PATIENTS VAD SPEED WAS INCREASED BY THE CLINIC FROM 5900 TO 6000. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS INTENDED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT REPAIR FOR OGO AND BEND RELIEF ON (B)(6) 2024. THE VAD SPEED WAS INCREASED TO 62000 PRIOR TO THE PROCEDURE. THE PATIENT HAD BEEN HAVING FREQUENT PULSATILITY INDEX (PI)EVENTS. A LOW FLOW ALARM OCCURRED ON (B)(6) 2024. LOG FILES WERE SENT FOR EVALUATION. 120 PULSATILITY (PI) EVENTS WERE CAPTURED IN THE EVENT LOG, THESE EVENTS COULD BE CONSIDERED ROUTINE. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILES. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS EXPECTED.

    Description of Event or Problem · 0

    USER FACILITY REPORT RECEIVED ON (B)(6) 2024 STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH LOW FLOWS THROUGH THE VAD. THE OUTFLOW OBSTRUCTION RELEASE WAS PERFORMED VIA LEFT ANTERIOR THORACOTOMY AND THE THROMBUS BETWEEN THE OUTFLOW GRAFT AND BEND RELIEF WAS REMOVED. THE PATIENT WAS RESTING AFTER SURGERY, AND THE FLOWS WERE BACK IN NORMAL RANGE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607357 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7557369 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention