BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13046332 · Received December 20, 2021

    Report

    Report Number
    2916596-2021-07324
    Event Type
    Death
    Date Received
    December 20, 2021
    Date of Event
    August 1, 2021
    Report Date
    February 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿INCREASED PULSATILITY INDEX IS ASSOCIATED WITH ADVERSE OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE RECIPIENTS¿ IDENTIFYING THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS) MAY BE RELATED TO DEATH. A TOTAL OF 49 HM3 PATIENTS WERE EVALUATED. PULSATILE AND RESISTIVE INDEXES, ATHEROSCLEROTIC CHANGES IN CAROTID ARTERIES AND ARTERIAL STIFFNESS [MEASURED BY ENDO-PAT 2000 AS THE AUGMENTATION INDEX STANDARDIZED FOR HEART RATE (AI@75)] WERE EVALUATED 3 AND 6 MONTHS AFTER LVAD IMPLANTATION. THE PULSATILITY INDEX MEASURED AT 3 MONTHS WAS POSITIVELY ASSOCIATED WITH INCREASED HAZARD RATIOS (HR) FOR DEATH [HR 9.8, 95% CONFIDENCE INTERVAL (CI) 1.62-59.42], WITH HR INCREASING AFTER ADDING AI@75 TO THE MODEL (HR 18.8, 95% CI 2.44-145.50). A TOTAL OF 7 HM3 PATIENTS EXPIRED. THE CAUSES OF DEATH WERE REPORTED AS: ISCHEMIC STROKE (1 PATIENT), HEMORRHAGIC STROKE (2 PATIENTS), SEPSIS (2 PATIENTS), MULTI ORGAN FAILURE (1 PATIENT), AND RIGHT HEART FAILURE (1 PATIENT). IN ADDITION, 17 HM3 PATIENTS WERE TRANSPLANTED AND 2 PATIENTS SUFFERED FROM NON-FATAL ISCHEMIC STROKES. TWELVE HM3 PATIENTS EXPERIENCED ADVERSE EVENTS RELATED TO NON-SURGICAL BLEEDING, 6 IN THE GASTROINTESTINAL TRACT, 1 IN THE URINARY TRACT, 2 IN THE RESPIRATORY TRACT, AND 3 IN OTHER LOCATIONS. IN ONE HM3 PATIENT, LVAD WAS REPLACED DUE TO THROMBOSIS. SIX PATIENTS WITH HM3 WERE TRANSIENTLY TREATED BY RVAD (MEAN DURATION OF 30.6 DAYS) SHORTLY AFTER IMPLANTATION OF LVAD, WHICH WAS SUCCESSFULLY REMOVED IN ALL PATIENTS. IT WAS CONCLUDED THAT THE RISK OF DEATH AND CEREBROVASCULAR EVENTS IN LVAD RECIPIENTS IS ASSOCIATED WITH INCREASED PULSATILITY INDEX IN CAROTID ARTERIES AND POTENTIATED BY INCREASED ARTERIAL STIFFNESS. THE SAME RISK IS ATTENUATED BY HM3 LVAD IMPLANTATION, BUT THIS EFFECT IS WEAKENED BY INCREASED ARTERIAL STIFFNESS THE ARTICLE DID NOT PROVIDE INFORMATION REGARDING WHETHER THE LVAD PATIENTS INCLUDED IN THE STUDY HAD EXPERIENCED ANY ADVERSE EVENTS, AND NO SPECIFIC CLINICAL SYMPTOMS WERE DESCRIBED. THE STUDY REFERENCED IN THE ARTICLE CONSISTED OF 49 HEARTMATE 3 LVAS PATIENTS; THEREFORE, THE SPECIFIC DEVICE AND OTHER CASE/PATIENT INFORMATION IS NOT AVAILABLE AND WAS NOT REQUESTED. NO PRODUCT WAS EVALUATED. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS THROMBOEMBOLISM AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. FURTHERMORE, THE IFU PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. THE STUDY REFERENCED IN THE ARTICLE CONSISTED OF 49 HEARTMATE 3 LVAS PATIENTS; THEREFORE, THE SPECIFIC DEVICE AND OTHER CASE/PATIENT INFORMATION IS NOT AVAILABLE, AND WAS NOT REQUESTED. NO PRODUCT WAS EVALUATED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS STROKE, BLEEDING, THROMBOSIS, SEPSIS, RIGHT HEART FAILURE, MULTIPLE TYPES OF ORGAN FAILURE (RENAL, HEPATIC DYSFUNCTION, ETC.), AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER WERE DOCUMENTED AS UNKNOWN. THE DEVICES WERE IMPLANTED AT TIME OF EVENT. THE EVENT DATE HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (AUGUST 2021) SINCE DDTE OF DATA COLLECTION WAS NOT PROVIDED. THE AUTHOR OF THE ARTICLE WAS LISTED AS FOLLOWS: ZUZANA TUCANOVA, ET AL. ESC HEART FAILURE 2021; 8: 4288¿4295. DOI: 10.1002/EHF2.13537; DEPARTMENT OF CARDIOVASCULAR SURGERY, INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE, VIDENSKA 1958/9, PRAGUE, 140 21, CZECH REPUBLIC. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IN TOTAL, 17 HM3 PATIENTS WERE TRANSPLANTED. ADDITIONALLY 2 HM3 PATIENTS SUFFERED FROM NON-FATAL ISCHEMIC STROKES. 12 HM3 PATIENTS EXPERIENCED ADVERSE EVENTS RELATED TO NON-SURGICAL BLEEDING, 6 IN THE GASTROINTESTINAL TRACT, 1 IN THE URINARY TRACT, 2 IN THE RESPIRATORY TRACT, AND 3 IN OTHER LOCATIONS. IN ONE HM3 PATIENT, LVAD WAS REPLACED DUE TO THROMBOSIS. SIX PATIENTS WITH HM3 WERE TRANSIENTLY TREATED BY RVAD (MEAN DURATION OF 30.6 DAYS) SHORTLY AFTER IMPLANTATION OF LVAD, WHICH WAS SUCCESSFULLY REMOVED IN ALL PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESEARCH ARTICLE "INCREASED PULSATILITY INDEX IS ASSOCIATED WITH ADVERSE OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE RECIPIENTS" IDENTIFIED THAT HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE RELATED TO DEATH. A TOTAL OF 49 HEARTMATE 3 PATIENTS WERE EVALUATED. THE PATIENT'S PULSATILE AND RESISTIVE INDEXES, ATHEROSCLEROTIC CHANGES IN ARTERIES (MEASURED BY DUPLEX ULTRASOUND), AND ARTERIAL STIFFNESS [MEASURED BY ENDO-PAT 2000 AS THE AUGMENTATION INDEX STANDARDIZATION FOR HEARTRATE (AI@75)] WERE EVALUATED AFTER 3 AND 6 MONTHS FOLLOWING LVAD IMPLANTATION. THE PULSATILITY INDEX MEASURED AT 3 MONTHS WAS POSITIVELY ASSOCIATED WITH INCREASED HAZARD RATIOS (HR) FOR DEATH [HR 9.8, 95% CONFIDENCE INTERVAL (CI) 1.62-59.42], WITH HR INCREASING AFTER ADDING AI@75 TO THE MODEL (HR 18.8, 95% CI 2.44-145.50). A TOTAL OF 7 HEARTMATE 3 PATIENTS DIED. THE CAUSES OF THE PATIENT'S DEATH WERE REPORTED AS: HEARTMATE 3 N=3/1 ISCHEMIC STROKE, 2 HEMORRHAGIC STROKE; HEARTMATE 3 N=2 SEPSIS; HEARTMATE 3 N=1 MULTI ORGAN FAILURE; HEARTMATE 3 N= 1 DUE TO RIGHT HEART FAILURE. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBERS ARE UNKNOWN. THE HEARTMATE 3 DEVICES WERE IMPLANTED AT THE TIME OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939778 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| L