BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 12456911 · Received September 10, 2021

    Report

    Report Number
    2916596-2021-04884
    Event Type
    Death
    Date Received
    September 10, 2021
    Date of Event
    August 10, 2021
    Report Date
    January 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 MEDICAL DEVICE PROBLEM CODE: CORRECTION. "2964 - INFUSION OR FLOW PROBLEM" CORRECTED TO "1384 - MECHANICAL PROBLEM". MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF CLOTS IN THE OUTFLOW GRAFT AND INFLOW CANNULA COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO PHOTOS OR IMAGES WERE SUBMITTED AND THE PUMP REMAINS IN USE. A DIRECT CORRELATION BETWEEN THE REPORTED MULTIORGAN FAILURE AND PATIENT CONDITION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ANALYSIS OF THE SUBMITTED LOG FILES CAPTURED LOW FLOW EVENTS CONSISTENT WITH THE REPORTED CLOTS. THE ACCOUNT REPORTED THAT THE PATIENT WAS EXPERIENCING LOW FLOW ALARMS. THE PATIENT HAD AN ARREST AND WAS PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (V-A ECMO). THEIR VAD HAD FLOWS OF 0 LPM, AND IT WAS DISCONNECTED. IMAGING SHOWED THAT THE OUTFLOW GRAFT AND INFLOW CANNULA WERE CLOTTED. THE PATIENT WAS IN PROGRESSIVE CARDIOGENIC SHOCK WITH MULTI ORGAN FAILURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. NO PRODUCT WAS AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 23NOV2016. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) LISTS POSSIBLE PUMP THROMBOSIS AND VARIOUS FORMS OF ORGAN FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 6 ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) CONTAINS INFORMATION REGARDING THE PREPARATION AND ATTACHMENT OF THE SEALED OUTFLOW GRAFT. THIS DOCUMENT 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. 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 FLOW AND/OR BLEEDING. THE HEARTMATE 3 LVAS IFU DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF CLOTS IN THE OUTFLOW GRAFT AND INFLOW CANNULA COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO PHOTOS OR IMAGES WERE SUBMITTED AND THE PUMP REMAINS IN USE. A DIRECT CORRELATION BETWEEN THE REPORTED MULTIORGAN FAILURE AND PATIENT CONDITION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ANALYSIS OF THE SUBMITTED LOG FILES CAPTURED LOW FLOW EVENTS CONSISTENT WITH THE REPORTED CLOTS. THE ACCOUNT REPORTED THAT THE PATIENT WAS EXPERIENCING LOW FLOW ALARMS. THE PATIENT HAD AN ARREST AND WAS PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (V-A ECMO). THEIR VAD HAD FLOWS OF 0 LPM, AND IT WAS DISCONNECTED. IMAGING SHOWED THAT THE OUTFLOW GRAFT AND INFLOW CANNULA WERE CLOTTED. THE PATIENT WAS IN PROGRESSIVE CARDIOGENIC SHOCK WITH MULTI ORGAN FAILURE. THE ACCOUNT COMMUNICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2021 DUE TO PULSELESS ELECTRICAL ACTIVITY (PEA), ARREST, AND RESPIRATORY FAILURE. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 23NOV2016. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), LISTS POSSIBLE PUMP THROMBOSIS AND VARIOUS FORMS OF ORGAN FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 6 ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) CONTAINS INFORMATION REGARDING THE PREPARATION AND ATTACHMENT OF THE SEALED OUTFLOW GRAFT. THIS DOCUMENT 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. 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 FLOW AND/OR BLEEDING. THE HEARTMATE 3 LVAS IFU DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. 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 PASSED AWAY ON (B)(6) 2021 DUE TO PULSELESS ELECTRICAL ACTIVITY (PEA), ARREST, AND RESPIRATORY FAILURE. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE VT ABLATION WAS REPORTED IN MFR REPORT#2916596-2021-04914. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-04885. IT WAS REPORTED THAT THE PATIENT HAD LOW FLOW ALARMS. THE PATIENT HAD EXCHANGED THEIR SYSTEM CONTROLLER WITH NO IMPROVEMENT TO FLOWS AND THEY WERE PRESENTED TO THE EMERGENCY DEPARTMENT (ED). UPON PRESENTATION, THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.2, LACTATE DEHYDROGENASE (LDH) WAS 318 U/L AND FLOWS WERE <1L AND THE PATIENT WAS IN CARDIOGENIC SHOCK. WITHIN 6 HOURS, THE PATIENT HAD AN ARREST AND WAS PLACED ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). GIVEN THAT THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) HAD FLOWS OF 0 LPM, IT WAS DISCONNECTED. IMAGING SHOWED THAT THE OUTFLOW GRAFT WAS CLOTTED OFF AND THERE WAS A CLOT SITTING ON TOP OF THE INFLOW CANNULA ON ECHOCARDIOGRAM. THE PATIENT HAD UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION A FEW WEEKS PRIOR TO PRESENTATION. THE PATIENT IS NOW IN PROGRESSIVE CARDIOGENIC SHOCK WITH MULTI-ORGAN FAILURE. TECHNICAL SERVICES REVIEWED THE LOG FILE AND CONFIRMED THE LOW FLOW EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352515 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 5746172

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Life Threatening| H| R| D