BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24927685 · Received April 20, 2026

    Report

    Report Number
    2916596-2026-02165
    Event Type
    Death
    Date Received
    April 20, 2026
    Date of Event
    December 1, 2022
    Report Date
    April 20, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DIVISION OF CARDIAC, THORACIC & VASCULAR SURGERY, DEPARTMENT OF SURGERY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEWYORK-PRESBYTERIAN HOSPITAL, NEW YORK, NY; DEPARTMENT OF SURGERY, CENTER FOR INNOVATION AND OUTCOMES RESEARCH, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEWYORK-PRESBYTERIAN HOSPITAL, NEW YORK, NY DIVISION OF CARDIOLOGY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEWYORK-PRESBYTERIAN HOSPITAL, NEW YORK, NY. HYNDS MA, HAYASHI H, KURLANSKY P, ZHAO Y, VINOGRADSKY AV, YUZEFPOLSKAYA M, COLOMBO PC, SAYER GT, URIEL N, NAKA Y, TAKEDA K, MEDIUM-TERM OUTCOMES OF CONCOMITANT AORTIC VALVE REPAIR IN PATIENTS WITH CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE, THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2024), DOI: HTTPS://DOI.ORG/10.1016/J.JTCVS.2024.05.016. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ARTICLE TITLED ¿MEDIUM-TERM OUTCOMES OF CONCOMITANT AORTIC VALVE REPAIR IN PATIENTS WITH CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE¿ AUTHORED BY HYNDS, ET AL, FOUND THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE RELATED TO AORTIC INSUFFICIENCY, HEART FAILURE, CEREBROVASCULAR ACCIDENT, MULTI ORGAN FAILURE, ARRHYTHMIA, BLEEDING, INFECTION, DEVICE THROMBUS, TRANSPLANT, DEVICE EXPLANT, AND DEATH. THE STUDY OBJECTIVE WAS TO ANALYZE THE DEVELOPMENT OF AORTIC INSUFFICIENCY (AI) IN PATIENTS WHO RECEIVED CENTRAL AORTIC VALVE REPAIR (AVR) WHEN UNDERGOING CONTINUOUS FLOW (CF)-LVAD IMPLANTATION. A RETROSPECTIVE REVIEW WAS CONDUCTED OF PATIENTS WHO UNDERWENT HEARTMATE II IMPLANTATION BETWEEN APRIL 2004 AND DECEMBER 2015 AND HEARTMATE 3 IMPLANTATION BETWEEN NOVEMBER 2014 AND NOVEMBER 2022 AT COLUMBIA UNIVERSITY IRVING MEDICAL CENTER (CUIMC). PATIENTS WHO HAD AORTIC INSUFFICIENCY CLASSIFIED AS MILD OR GREATER HAD CONCOMITANT AORTIC VALVE REPAIR. CLINICAL CHARACTERISTICS, SERIAL ECHOCARDIOGRAMS, AND OUTCOMES WERE DETERMINED. ECHOCARDIOGRAPHIC ASSESSMENTS OF AI WERE AVAILABLE PREOPERATIVELY AND APPROXIMATED POSTOPERATIVELY AT 1 MONTH, 1 YEAR, 2 YEARS, AND 3 YEARS POST-IMPLANTATION. AI WAS GRADED BY THE COLUMBIA UNIVERSITY CARDIOLOGY ECHOCARDIOGRAM LABORATORY AS NONE, TRACE, MILD, MILD TO MODERATE, MODERATE, MODERATE TO SEVERE, OR SEVERE. SIGNIFICANT AI WAS DEFINED AS MODERATE OR GREATER AI. PATIENTS WERE FOLLOWED WITHIN THE STUDY TIME UNTIL CARDIAC TRANSPLANT, DEVICE EXPLANT, DEATH, LOSS TO FOLLOW UP, OR THE END OF THE REVIEW PERIOD. THE PRIMARY OUTCOME OF INTEREST WAS PROGRESSION TO MODERATE OR GREATER AI POST-IMPLANTATION. THE SECONDARY ENDPOINT OF INTEREST WAS SURVIVAL AT 3 YEARS POST-IMPLANTATION. OF THE 656 PATIENTS WHO UNDERWENT HEARTMATE II OR 3 IMPLANTATION, 105 PATIENTS (59 HEARTMATE II AND 46 HEARTMATE 3) MET STUDY CRITERIA. PREOPERATIVE AORTIC INSUFFICIENCY DEGREE WAS 54.3% (N = 57 PATIENTS) MILD, 23.8% (N = 25) MILD-TO-MODERATE, 20.0% (N = 21) MODERATE, 1.0% (N = 1) MODERATE-TO-SEVERE, 1.0% (N = 1) SEVERE. FREEDOM FROM MODERATE OR MORE SEVERE AORTIC INSUFFICIENCY WAS 96.4%, 93.3%, AND 91.0% AT 1-YEAR, 2-YEAR, AND 3-YEAR POST-IMPLANTATION, RESPECTIVELY. AT 1, 2, AND 3-YEAR FOLLOW UPS, THE CUMULATIVE SURVIVAL PROBABILITY WAS 0.886, 0.717, AND 0.634, RESPECTIVELY. OF THE HEARTMATE 3 PATIENTS, 14 PATIENTS DIED, AND 8 PATIENTS UNDERWENT CARDIAC TRANSPLANTATION DURING THE FOLLOW UP PERIOD. FOR THE 14 DECEASED HEARTMATE 3 PATIENTS, CAUSES OF DEATH INCLUDED DEVICE DEACTIVATION BECAUSE OF: COMPLICATIONS OF WORSENING RIGHT HEART FAILURE (N = 5), CEREBROVASCULAR ACCIDENTS (N = 1), MULTIORGAN FAILURE (N = 1), RESPIRATORY FAILURE (N = 2), AND PATIENT DECISION (N = 3). THE CAUSE OF DEATH FOR 2 PATIENTS WAS UNKNOWN DUE TO THE EVENT TAKING PLACE EXTERNALLY. READMISSION RATES FOR STROKE (N = 11), HEART FAILURE/VOLUME OVERLOAD (N = 25), SEVERE AI (N = 1), DEVICE-RELATED INFECTION (N = 16): 9 DRIVELINE INFECTIONS, 5 STERNAL WOUND INFECTIONS, AND 2 POCKET INFECTIONS, HEARTMATE 3 DEVICE THROMBUS (N = 2), AND LOW FLOW ALARMS (N = 7) WERE ANALYZED TO ASSESS POST-IMPLANT MORBIDITY. EARLY POST-OPERATIVE DATA INCLUDED INCIDENCES OF HOSPITAL MORTALITY (N = 6), POST-OP RIGHT VENTRICULAR ASSIST DEVICE (RVAD) REQUIRED (N = 8), VENTRICULAR TACHYCARDIA OR FIBRILLATION (N = 25), ATRIAL FIBRILLATION OR FLUTTER (N = 32), SEPSIS (N = 19), URINARY TRACT INFECTION (N = 17), STROKE (N = 4), TAKEBACK FOR BLEEDING (N = 17), AND DIALYSIS (N = 9). THE PROPORTION OF AVR PATIENTS WITH MODERATE OR GREATER AI INCREASED FROM 1% AT 1 MONTH TO 6.0% AT 1-YEAR THEN DECREASED TO 4.5% AT 2-YEAR AND 3.2% AT 3-YEAR FOLLOW-UP. THE PROPORTION OF AVR PATIENTS WITH NO DETECTABLE AI WAS 49.0% AT 1 MONTH, 31.3% AT 1-YEAR, 40.9% AT 2-YEAR AND 25.8% AT 3-YEAR FOLLOW UP. NO AVR PATIENTS EXPERIENCED SEVERE AI AT 1, 2, OR 3-YEAR FOLLOW UP. FOUR AVR PATIENTS DEVELOPED MODERATE AI AT 1-YEAR FOLLOW UP. TWO AVR PATIENTS DEVELOPED MODERATE AI AT 2-YEAR FOLLOW UP. ONE AVR PATIENT DEVELOPED MODERATE AI AT 3-YEAR FOLLOW UP. HEARTMATE 3 PATIENTS HAD FREEDOM FROM MODERATE AI PROBABILITY OF 1.000 AT 1 YEAR, 0.100 AT 2 YEARS, AND 0.960 AT 3 YEARS. OF THE PATIENTS WHO EXPERIENCED MODERATE OR GREATER AI, 3 PATIENTS REQUIRED READMISSIONS FOR RIGHT HEART FAILURE. ONE PATIENT WAS READMITTED WITH SYMPTOMS OF EDEMA AND WEIGHT GAIN 1 MONTH PRIOR TO THEIR 1-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING. ANOTHER PATIENT WAS ADMITTED WITH SYMPTOMS OF SHORTNESS OF BREATH AND DECREASED EXERCISE TOLERANCE TWO DAYS BEFORE THEIR 2-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING; THEIR AI WAS ADDRESSED WITH SPEED OPTIMIZATION. THE THIRD PATIENT WAS READMITTED WITH SYMPTOMS OF SHORTNESS OF BREATH ON EXERTION ONE YEAR PRIOR TO THEIR 3-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING. THE STUDY CONCLUDED THAT CENTRAL AORTIC VALVE REPAIR MAY BE AN EFFECTIVE TECHNIQUE TO MITIGATE AORTIC INSUFFICIENCY IN HEARTMATE II AND 3. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH, STROKE, AND BLEEDING. THE IFU ALSO LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RIGHT HEART FAILURE, RESPIRATORY FAILURE, RENAL DYSFUNCTION, AND HEPATIC DYSFUNCTION) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE¿) OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. SECTION 6 ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 ARTICLE ¿MEDIUM-TERM OUTCOMES OF CONCOMITANT AORTIC VALVE REPAIR IN PATIENTS WITH CONTINUOUS-FLOW (CF) LEFT VENTRICULAR ASSIST DEVICE¿ THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE RELATED TO AORTIC INSUFFICIENCY, HEART FAILURE, CEREBROVASCULAR ACCIDENT, MULTI ORGAN FAILURE, ARRHYTHMIA, BLEEDING, INFECTION, DEVICE THROMBUS, TRANSPLANT, DEVICE EXPLANT, AND DEATH. THE OBJECTIVE WAS TO ANALYZE THE DEVELOPMENT OF AORTIC INSUFFICIENCY IN PATIENTS WHO RECEIVED CENTRAL AORTIC VALVE REPAIR WHEN UNDERGOING CF-LVAD IMPLANTATION. THE STUDY ALSO EVALUATED THE LONG-TERM RISK OF DEVELOPMENT OF MODERATE OR GREATER AI IN HEARTMATE II AND HEARTMATE 3 PATIENTS WHO UNDERWENT AORTIC VALVE REPLACEMENT (AVR). A RETROSPECTIVE REVIEW WAS CONDUCTED OF PATIENTS WHO UNDERWENT HEARTMATE II IMPLANTATION BETWEEN APRIL 2004 AND DECEMBER 2015 AND HEARTMATE 3 IMPLANTATION BETWEEN NOVEMBER 2014 AND NOVEMBER 2022 AT COLUMBIA UNIVERSITY IRVING MEDICAL CENTER (CUIMC). NINETY-FOUR PATIENTS WERE EXCLUDED FROM ANALYSIS FOR HISTORY OF AORTIC VALVE PROCEDURES, A BICUSPID AORTIC VALVE, BASELINE TRACE AORTIC INSUFFICIENCY, OR OTHER CONCOMITANT AORTIC VALVE PROCEDURE. PATIENTS WHO HAD MILD AORTIC INSUFFICIENCY HAD CONCOMITANT AORTIC VALVE REPAIR. CLINICAL CHARACTERISTICS, SERIAL ECHOCARDIOGRAMS, AND OUTCOMES WERE DETERMINED. ECHOCARDIOGRAPHIC ASSESSMENTS, WHETHER TRANSTHORACIC OR TRANSESOPHAGEAL, OF AI WERE AVAILABLE PREOPERATIVELY AND APPROXIMATED POSTOPERATIVELY AT 1 MONTH (WITHIN 1-MONTH POST-IMPLANT), 1 YEAR (BETWEEN 6- AND 18-MONTHS POST-IMPLANT), 2 YEARS (BETWEEN 19- AND 29-MONTHS POST-IMPLANT) AND 3 YEARS POST-IMPLANTATION (BETWEEN 30- AND 42-MONTHS POST-IMPLANT). AORTIC INSUFFICIENCY (AI) WAS GRADED BY THE COLUMBIA UNIVERSITY CARDIOLOGY ECHOCARDIOGRAM LABORATORY AS NONE, TRACE, MILD, MILD TO MODERATE, MODERATE, MODERATE TO SEVERE, OR SEVERE. SIGNIFICANT AORTIC INSUFFICIENCY WAS DEFINED AS MODERATE OR GREATER AI. PATIENT DATA INCLUDING DEMOGRAPHICS, CO-MORBIDITIES, PERIOPERATIVE VARIABLES, AND POSTOPERATIVE EVENTS WERE ABSTRACTED RETROSPECTIVELY FROM THE ELECTRONIC MEDICAL RECORD. PATIENTS WERE FOLLOWED WITHIN THE STUDY TIME UNTIL CARDIAC TRANSPLANT, DEVICE EXPLANT, DEATH, LOSS TO FOLLOW UP, OR THE END OF THE REVIEW PERIOD. THE PRIMARY OUTCOME OF INTEREST WAS PROGRESSION TO MODERATE AI POST-IMPLANTATION. THE SECONDARY ENDPOINT OF INTEREST WAS SURVIVAL AT 3 YEARS POST-IMPLANTATION. OF THE 656 PATIENTS WHO UNDERWENT HEARTMATE II OR 3 IMPLANTATION, 105 PATIENTS (59 HEARTMATE II AND 46 HEARTMATE 3) MET STUDY CRITERIA. MEDIAN AGE WAS 68 YEARS [60-74 YEARS], 91.4% [N=96] WERE MALE, 54.4% [N=56] WERE WHITE, AND 68.6% [N=72] RECEIVED SUPPORT AS DESTINATION THERAPY. PREOPERATIVE AORTIC INSUFFICIENCY DEGREE WAS 54.3% (N=57) MILD, 23.8% (N=25) MILD-TO-MODERATE, 20.0% (N=21) MODERATE, 1.0% (N=1) MODERATE-TO-SEVERE, 1.0% (N=1) SEVERE. IN HOSPITAL MORTALITY WAS 5.7% [N=6]. FREEDOM FROM MODERATE AORTIC INSUFFICIENCY WAS 96.4% (95%CI: 92.5%-100%), 93.3% (95%CI: 87.6%-99.2%), AND 91.0% (95%CI: 84.1%-98.5%) AT 1-YEAR, 2-YEAR, AND 3-YEAR POST-IMPLANTATION, RESPECTIVELY. THREE-YEAR SURVIVAL WAS 63.4% [95%CI: 52.9%-75.9%]. OF THE HEARTMATE 3 PATIENTS, 14 PATIENTS DIED, AND 8 PATIENTS UNDERWENT CARDIAC TRANSPLANTATION DURING THE FOLLOW UP PERIOD. FOR THE 14 DECEASED HEARTMATE 3 PATIENTS, CAUSES OF DEATH INCLUDED DEVICE DEACTIVATION BECAUSE OF: COMPLICATIONS OF WORSENING RIGHT HEART FAILURE (N = 5), CEREBROVASCULAR ACCIDENTS (N = 1), MULTIORGAN FAILURE (N = 1), RESPIRATORY FAILURE (N = 2), AND PATIENT DECISION (N = 3). THE CAUSE OF DEATH FOR 2 PATIENTS WAS UNKNOWN DUE TO THE EVENT TAKING PLACE EXTERNALLY. EARLY POST-OPERATIVE DATA INCLUDED IN HOSPITAL MORTALITY (6), POST-OP RVAD REQUIRED (8), VENTRICULAR TACHYCARDIA OR FIBRILLATION (25), ATRIAL FIBRILLATION OR FLUTTER (32), SEPSIS (19), URINARY TRACT INFECTION (17), STROKE (4), TAKEBACK FOR BLEEDING (17), AND DIALYSIS (9). READMISSION RATES FOR STROKE (11) HEART FAILURE/VOLUME OVERLOAD (25) SEVERE AI (1), DEVICE-RELATED INFECTION (16): 9 DRIVELINE INFECTIONS, 5 STERNAL WOUND INFECTIONS AND 2 POCKET INFECTIONS, 2 HM3 DEVICE THROMBUS AND 7 FLOW ALARMS WERE ANALYZED TO ASSESS POST-IMPLANT MORBIDITY. ONLY ONE PATIENT WAS READMITTED FOR SEVERE AI. THE PROPORTION OF AVR PATIENTS WITH MODERATE OR GREATER AI INCREASED FROM 1% AT 1 MONTH TO 6.0% AT 1-YEAR THEN DECREASED TO 4.5% AT 2-YEAR AND 3.2% AT 3-YEAR FOLLOW-UP. THE PROPORTION OF AVR PATIENTS WITH NO DETECTABLE AI WAS 49.0% AT 1 MONTH, 31.3% AT 1-YEAR, 40.9% AT 2-YEAR AND 25.8% AT 3-YEAR FOLLOW UP. NO AVR PATIENTS EXPERIENCED SEVERE AI AT 1, 2, OR 3-YEAR FOLLOW UP. FOUR AVR PATIENTS DEVELOPED MODERATE AI AT 1-YEAR FOLLOW UP. TWO AVR PATIENTS DEVELOPED MODERATE AI AT 2-YEAR FOLLOW UP. ONE AVR PATIENT DEVELOPED MODERATE AI AT 3-YEAR FOLLOW UP. HEARTMATE 3 PATIENTS HAD FREEDOM FROM MODERATE AI PROBABILITY OF 1.000 (95% CI: 1.000, 1.000) AT 1 YEAR, 0.100 (95% CI: 1.000, 1.000) AT 2 YEARS, AND 0.960 (95% CI: 0.886, 1.000) AT 3 YEARS. OF THE PATIENTS WHO EXPERIENCED MODERATE OR GREATER AI, 3 PATIENTS REQUIRED READMISSIONS FOR RIGHT HEART FAILURE. ONE PATIENT WAS READMITTED WITH SYMPTOMS OF EDEMA AND WEIGHT GAIN 1 MONTH PRIOR TO THEIR 1-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING. ANOTHER PATIENT WAS ADMITTED WITH SYMPTOMS OF SHORTNESS OF BREATH AND DECREASED EXERCISE TOLERANCE TWO DAYS BEFORE THEIR 2-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING; THEIR AI WAS ADDRESSED WITH SPEED OPTIMIZATION. THE THIRD PATIENT WAS READMITTED WITH SYMPTOMS OF SHORTNESS OF BREATH ON EXERTION ONE YEAR PRIOR TO THEIR 3-YEAR MODERATE AI ECHOCARDIOGRAPHIC FINDING. THE KAPLAN-MEIER METHOD WAS USED TO ASSESS SURVIVAL PROBABILITY (FIGURE 2). AT 1-YEAR FOLLOW UP, THE CUMULATIVE SURVIVAL PROBABILITY WAS 0.886 (95% CI: 0.824, 0.952). AT 2-YEAR FOLLOW UP, THE SURVIVAL PROBABILITY WAS 0.717 (95% CI: 0.620, 0.829). AT 3-YEAR FOLLOW UP, THE PROBABILITY WAS 0.634 (95% CI: 0.529, 0.759). IN CONCLUSION, CENTRAL AORTIC VALVE REPAIR MAY BE AN EFFECTIVE TECHNIQUE TO MITIGATE AORTIC INSUFFICIENCY IN HEARTMATE II AND 3. A LARGER COHORT STUDY WITH LONGER DURATION OF FOLLOW UP IS WARRANTED TO FURTHER INVESTIGATE THE CLINICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985177 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death