BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22018838 · Received May 14, 2025

    Report

    Report Number
    2916596-2025-02910
    Event Type
    Death
    Date Received
    May 14, 2025
    Date of Event
    October 1, 2022
    Report Date
    June 6, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO HEARTMATE 3 LVAD¿S WERE RETURNED FOR THIS EVALUATION. THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) 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. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (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.

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01OCT2022 AS PATIENTS WERE IMPLANTED BETWEEN 01OCT2006 AND 01OCT2022. OATES, C.P.; LAWRENCE, L.L.; BIGHAM, G.E.; MEDA, N.S.; BASYAL, B; ET AL (2025). IMPACT OF CARDIAC RESYNCHRONIZATION THERAPY ON VENTRICULAR ARRHYTHMIAS AND SURVIVAL AFTER DURABLE LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION. ASAIO JOURNAL, 71(2), 157-163. HTTP://DX.DOI.ORG/10.1097/MAT.0000000000002279. THE MEDSTAR HEART AND VASCULAR INSTITUTE, MEDSTAR WASHINGTON HOSPITAL CENTER, WASHINGTON, DC, UNITED STATES, GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE, WASHINGTON, DC, UNITED STATES, DEPARTMENT OF CARDIOLOGY, HELMSLEY ELECTROPHYSIOLOGY CENTER, ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, NEW YORK, NY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RETROSPECTIVE COHORT STUDY "IMPACT OF CARDIAC RESYNCHRONIZATION THERAPY ON VENTRICULAR ARRHYTHMIAS AND SURVIVAL AFTER DURABLE LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION" MAY BE ASSOCIATED WITH VENTRICULAR ARRHYTHMIAS, INFECTION, HEMATOMA, RESPIRATORY FAILURE, RIGHT VENTRICULAR ASSIST DEVICE IMPLANTATION, RIGHT VENTRICLE FAILURE, AND DEATH. THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY EVALUATED THE IMPACT OF POSTOPERATIVE MANAGEMENT OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) ON CLINICAL OUTCOMES FOLLOWING LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. ALL PATIENTS 18 YEARS OLD AND ABOVE WHO WERE IMPLANTED AT THE STUDY HOSPITAL WERE CONSIDERED FOR THE STUDY. A TOTAL OF 789 PATIENTS UNDERWENT LVAD IMPLANTATION, FROM 01OCT2006 TO 01OCT2022, INCLUDING 195 PATIENTS (24.7%) WITH PREOPERATIVE CRT. THE HEARTMATE 3 (HM3) WAS THE MOST COMMON DEVICE IMPLANTED (41.4%), WHEREAS 34.6% OF PATIENTS RECEIVED A HEART WARE VENTRICULAR ASSIST DEVICE (HVAD) DEVICE AND 23.8% OF PATIENTS RECEIVED A HEARTMATE II (HMII). OF NOTE, PATIENTS WITH PREOPERATIVE CRT IN WHOM CHARACTERIZATION OF POSTOPERATIVE DEVICE MANAGEMENT WAS NOT POSSIBLE WERE EXCLUDED FROM ANALYSIS. THE MEAN PATIENT AGE AT LVAD IMPLANTATION WAS 62.9 YEARS. THE MAJORITY OF PATIENTS WERE MEN (73.3%). AFTER LVAD IMPLANTATION, 42 HM3 PATIENTS HAD CRT PROGRAMMED ¿OFF¿ AND 74 HM3 PATIENTS HAD CRT PROGRAMMED ¿ON.¿ PATIENTS WITH PREOPERATIVE CRT WHO DID NOT HAVE DATA DETAILING POSTOPERATIVE CRT PROGRAMMING WERE EXCLUDED FROM THE ANALYSIS (N = 36). MAINTAINING CRT ¿ON¿ WAS ASSOCIATED WITH A SIGNIFICANTLY GREATER RISK OF MORTALITY COMPARED TO PROGRAMMING CRT ¿OFF¿ AFTER LVAD IMPLANTATION AFTER ADJUSTING FOR AGE, SEX, AND RACE (SDHR = 1.54; 1.06¿2.37 95% CI; P = 0.036). PATIENTS WITH CRT ¿OFF¿ HAD SIGNIFICANTLY LONGER MEDIAN SURVIVAL TIME ON LVAD SUPPORT COMPARED TO PATIENTS WITH CRT ¿ON¿ (970 DAYS [462¿1,821] VS. 496 DAYS [208¿953]; P = 0.001). HEART TRANSPLANTATION OCCURRED EQUALLY IN PATIENTS WITH CRT ¿ON¿ AND CRT ¿OFF¿ (13.5% VS. 14.1%; P = 0.613) AFTER SIMILAR WAIT TIMES (659 DAYS [386¿1,406] VS. 548 DAYS [247¿698]; 0.375) (THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN INCIDENCE OF VENTRICULAR ARRHYTHMIAS IN PATIENTS WITH AND WITHOUT POSTOPERATIVE CRT ¿ON¿ (35.1% VS. 48.2%; P = 0.095). OF THE 85 PATIENTS WITH CRT TURNED ¿OFF¿ FOLLOWING LVAD IMPLANTATION, 18 PATIENTS WERE DEPENDENT ON RV-ONLY PACING AND RV PACED >95% OF THE TIME. COMPARED TO PATIENTS WITH RV-ONLY PACING, BIVENTRICULAR PACING (LV LEAD ¿ON¿) WAS ASSOCIATED WITH A HIGHER RISK OF MORTALITY AFTER ADJUSTING FOR AGE, SEX, AND RACE (SDHR = 2.61; 1.19¿5.75 95% CI; P = 0.017). THE PRIMARY CLINICAL OUTCOMES OF THE STUDY WERE TRANSPLANT FREE SURVIVAL AND INCIDENCE OF POSTOPERATIVE VENTRICULAR ARRHYTHMIAS. TRANSPLANT-FREE SURVIVAL WAS DEFINED AS TIME FROM INDEX LVAD IMPLANTATION TO TRANSPLANTATION, LVAD EXPLANT, DEATH, OR MOST RECENT FOLLOW-UP. IT WAS NOTED THAT IN TOTAL 67 PATIENTS EXPERIENCED A VENTRICULAR ARRHYTHMIA, 26 PATIENTS WERE TRANSPLANTED, 80 PATIENTS PASSED AWAY, OF WHICH 35 PATIENTS PASSED AWAY DUE TO AN UNSPECIFIED CARDIOVASCULAR OUTCOME, WHILE 45 PATIENTS PASSED AWAY DUE TO AN UNSPECIFIED NON-CARDIOVASCULAR OUTCOME. IT WAS NOTED THAT AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED RESPIRATORY FAILURE OR REQUIRED RIGHT VENTRICULAR ASSIST DEVICES. ADDITIONALLY, IT WAS NOTED THAT 25.5% OF PATIENTS IN THE CRT OFF CATEGORY HAD COMPLETE HEART BLOCK. PROCEDURE RELATED HEMATOMA¿S, INFECTION, AND RIGHT VENTRICLE FAILURE WERE ALSO REPORTED TO HAVE OCCURRED, THOUGH THE AMOUNT OF THESE EVENTS WAS NOT PROVIDED, HOWEVER IT WAS REPORTED AT LEAST ONE PATIENT REQUIRED A WASHOUT DUE TO A HEMATOMA, AND ANOTHER PATIENT EXPERIENCED A BLOOD STREAM INFECTION. FINALLY, IT WAS REPORTED THAT SOME PATIENTS EXPERIENCED POSTOPERATIVE SHOCK AND REQUIRED VASOPRESSOR MEDICATIONS. IN CONCLUSION, MAINTAINING CRT ¿ON¿ AFTER LVAD IMPLANTATION, AND POSTOPERATIVE MANAGEMENT OF CRT WAS NOT ASSOCIATED WITH INCIDENCE OF VENTRICULAR ARRHYTHMIAS POST IMPLANT, BUT WAS ASSOCIATED WITH INCREASED RISK OF MORTALITY FOLLOWING LVAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748748 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death