BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 13026345 · Received December 17, 2021

    Report

    Report Number
    2916596-2021-07355
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    January 1, 2017
    Report Date
    December 17, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESEARCH ABSTRACT REFERENCE: SUNG-MIN CHO, ET AL. NEUROSCIENCE CRITICAL CARE DIVISION, DEPARTMENTS OF NEUROLOGY, NEUROSURGERY, AND ANESTHESIOLOGY AND CRITICAL CARE MEDICINE, (B)(6) HOSPITAL/(B)(6) UNIVERSITY SCHOOL OF MEDICINE, (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS (TRANSIENT ISCHEMIC ATTACK, ISCHEMIC/EMBOLIC STROKE, AND HEMORRHAGIC STROKE) CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A STUDY CONDUCTED BY (B)(6) HOSPITAL/(B)(6) UNIVERSITY SCHOOL OF MEDICINE STATED THAT ISCHEMIC AND HEMORRHAGIC CEREBROVASCULAR ACCIDENTS REMAIN COMMON AMONG PATIENTS WITH CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES, DESPITE IMPROVEMENTS IN SURVIVAL AND DEVICE LONGEVITY. THE STUDY SOUGHT TO COMPARE THE INCIDENCE OF NEUROLOGIC ADVERSE EVENTS (NAES) ASSOCIATED WITH 2 CONTEMPORARY CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES: THE ABBOTT HEARTMATE3 (HM3) AND THE MEDTRONIC HEARTWARE VENTRICULAR ASSIST DEVICE (HVAD). USING THE SOCIETY OF THORACIC SURGEONS INTERAGENCY REGISTRY FOR MECHANICALLY ASSISTED CIRCULATORY SUPPORT (INTERMACS), THE STUDY COLLECTED DATA ON ADULT PATIENTS WHO RECEIVED A CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICE (LVAD) AS A PRIMARY ISOLATED IMPLANT BETWEEN (B)(6) 2017, AND (B)(6) 2019. MAJOR NAES WERE DEFINED AS TRANSIENT ISCHEMIC ATTACK, ISCHEMIC CEREBROVASCULAR ACCIDENT, OR HEMORRHAGIC CEREBROVASCULAR ACCIDENT. THE ASSOCIATION OF THE HVAD WITH THE RISK OF NAE IN THE FIRST YEAR AFTER IMPLANT WAS EVALUATED USING PROPENSITY SCORE MATCHING TO BALANCE FOR PREIMPLANT RISK FACTORS. AFTER MATCHING, FREEDOM FROM FIRST MAJOR NAE IN THE HM3 AND HVAD COHORTS WAS COMPARED WITH KAPLAN-MEIER CURVES. A SECONDARY ANALYSIS USING MULTIVARIABLE MULTIPHASE HAZARD MODELS WAS USED TO IDENTIFY PREDICTORS OF NAE, WHICH USES A DATA-DRIVEN PARAMETRIC FIT OF THE EARLY DECLINING AND CONSTANT PHASE HAZARDS AND THE ASSOCIATIONS OF RISK FACTOR WITH EITHER PHASE. OF 6205 INCLUDED PATIENTS, 3129 (50.4%) RECEIVED THE HM3 AND 3076 (49.6%) RECEIVED THE HVAD. MEDIAN FOLLOW UP WAS 9 AND 12 MONTHS (HM3 AND HVAD, RESPECTIVELY). PATIENTS RECEIVING HVAD HAD MORE MAJOR NAES (16.4% VERSUS 6.4%, OF 6205 INCLUDED PATIENTS, 3129 (50.4%) RECEIVED THE HM3 AND 3076 (49.6%) RECEIVED THE HVAD. THE MEDIAN FOLLOW-UP WAS 9 AND 12 MONTHS (HM3 AND HVAD, RESPECTIVELY). PATIENTS IMPLANTED WITH AN HVAD HAD MORE MAJOR NAES (16.4% VERSUS 6.4%, P 0.001) AS WELL AS EACH SUBTYPE (TRANSIENT ISCHEMIC ATTACK: 3.3% VERSUS 1.0%, P 0.001; ISCHEMIC CEREBROVASCULAR ACCIDENT: 7.7% VERSUS 3.4%, P 0.001; HEMORRHAGIC CEREBROVASCULAR ACCIDENT: 7.2% VERSUS 2.0%, P 0.001) THAN DID PATIENTS IMPLANTED WITH THE HM3. A PROPENSITY-MATCHED COHORT BALANCED FOR PREIMPLANT RISK FACTORS SHOWED THAT HVAD WAS ASSOCIATED WITH HIGHER PROBABILITIES OF MAJOR NAES (% FREEDOM FROM NAE 82% VERSUS 92%, P 0.001). DEVICE TYPE WAS NOT SIGNIFICANTLY ASSOCIATED WITH NAES IN THE EARLY HAZARD PHASE, BUT THE HVAD WAS ASSOCIATED WITH A HIGHER INCIDENCE OF MAJOR NAES DURING THE CONSTANT HAZARD PHASE (HAZARD RATIO, 5.71 CI, 3.90¿8.36]). THE STUDY CONCLUDED THAT THE HM3 IS ASSOCIATED WITH A LOWER HAZARD OF MAJOR NAES THAN THE HVAD BEYOND THE EARLY POST-IMPLANTATION PERIOD AND DURING THE CONSTANT HAZARD PHASE. DEFINING THE EXPLANATION FOR THIS OBSERVATION WILL INFORM DEVICE SELECTION FOR INDIVIDUAL PATIENTS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE LISTS BLEEDING, STROKE, AND OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) IS ALSO PROVIDED IN THIS DOCUMENT. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED BECAUSE THE SERIAL NUMBERS OF THE IMPLANTED HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICES ARE UNKNOWN. THE REFERENCED STUDY CONSISTED OF 3129 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE PATIENTS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE AND WERE NOT REQUESTED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. C, CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS BLEEDING, STROKE, AND OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OUTLINES RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT "CEREBROVASCULAR EVENTS IN PATIENTS WITH CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES: A PROPENSITY SCORE MATCHED ANALYSIS" THAT HEARTMATE 3 (HM3) DEVICES MAY BE RELATED TO ISCHEMIC AND HEMORRHAGIC CEREBROVASCULAR ACCIDENTS (CVAS). THE DATA WAS EXTRACTED FROM INTERMACS THROUGH AN ANALYSIS OF PATIENTS WHO RECEIVED LEFT VENTRICULAR ASSIST DEVICES (LVADS) BETWEEN (B)(6)2017 AND (B)(6) 2019. OF THE 6,205 INCLUDED PATIENTS, 3,076 (49.6%) RECEIVED THE HM3, AND MEDIAN FOLLOW-UP WAS BETWEEN 9 AND 12 MONTHS. OBSERVATIONAL DATA FROM THE INTERMACS REGISTRY SUGGESTED THAT HM3 IS ASSOCIATED WITH LOWER HAZARD OF MAJOR NEGATIVELY ADJUDICATED EVENTS (NAE) BEYOND THE PERI-OPERATIVE PERIOD THAN THE HVAD IS. THE RESULTS WERE CONSISTENT ACROSS SEVERAL DIFFERENT ANALYSES, INCLUDING KAPLAN-MEIER ANALYSES OF FREEDOM FROM FIRST MAJOR NAES (80% VS. 93% AT 1 YEAR) AND HAZARD ANALYSIS (HR, 5.71).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927947 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other