BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21563886 · Received March 10, 2025

    Report

    Report Number
    2916596-2025-01188
    Event Type
    Death
    Date Received
    March 10, 2025
    Date of Event
    September 25, 2024
    Report Date
    March 10, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: DATE OF DEATH WAS ESTIMATED AS DATE OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION (25SEP2024) AS THE DATE OF DATA COLLECTION WAS NOT PROVIDED. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. AUTHOR INFORMATION: NORDAN, T., KESHK, K., HACKMANN, A., GIVERTZ, M. M., MEHRA, M. R., CUNNINGHAM, M. J., ITOH, A. THE IMPACT OF BLOOD TYPE AND BODY SIZE ON SUCCESSFUL BRIDGING TO HEART TRANSPLANTATION USING INTRA-AORTIC BALLOON PUMP OR SURGICALLY IMPLANTED MICROAXIAL LEFT VENTRICULAR ASSIST DEVICE. (2024). JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY. HTTPS://DOI.ORG/10.1016/J.JTCVS.2024.10.013. (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 ¿THE IMPACT OF BLOOD TYPE AND BODY SIZE ON SUCCESSFUL BRIDGING TO HEART TRANSPLANTATION USING INTRA-AORTIC BALLOON PUMP OR SURGICALLY IMPLANTED MICROAXIAL LEFT VENTRICULAR ASSIST DEVICE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH DEATH. THE ARTICLE COMPARED A BRIDGING STRATEGY USING EITHER THE IMPELLA 5.0/5.5 (¿IMPELLA¿) OR INTRA-AORTIC BALLOON PUMP WITH A DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IN PATIENTS WITH BLOOD TYPE O STRATIFIED BY BODY HABITUS. THE UNITED NETWORK FOR ORGAN SHARING REGISTRY WAS QUERIED FOR ADULTS LISTED FOR DE NOVO HEART TRANSPLANTATION (WITHOUT DIALYSIS) SUPPORTED BY THE IMPELLA OR THE HEARTMATE 3 (HM3) LVAD. THERE WERE 1402 LVAD PATIENTS HAD AN AVERAGE AGE OF 56 AND AVERAGE BMI OF 29.6. 102 PATIENTS HAD HISTORY OF STROKE, 719 WERE PRIOR SMOKERS, 457 HAD DIABETES, 1019 WERE IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). THE PRIMARY OUTCOME WAS 1-YEAR POSTLISTING SURVIVAL, DEFINED AS THE SUM OF WAITLIST TIME AND POST¿HEART TRANSPLANT SURVIVAL TIME IF THE CANDIDATE UNDERWENT HEART TRANSPLANTATION. 2942 CANDIDATES WERE INCLUDED (IMPELLA: 214: 1326; HEARTMATE 3: 1402). LISTING WITH THE IMPELLA OR INTRA-AORTIC BALLOON PUMP WAS ASSOCIATED WITH WORSE POSTLISTING SURVIVAL COMPARED WITH THE HEARTMATE 3 LVAD IN TYPE O CANDIDATES (IMPELLA: HAZARD RATIO, 2.90 [95% CI, 1.48-5.67], P ¼ .002; INTRA-AORTIC BALLOON PUMP: HAZARD RATIO, 2.42 [95% CI, 1.59-3.68], P < .001) BUT LESS SO IN NON¿TYPE O CANDIDATES. FURTHER ANALYSIS OF TYPE O CANDIDATES DEMONSTRATED THAT THE IMPELLA AND INTRA-AORTIC BALLOON PUMP WERE ASSOCIATED WITH A LOWER RISK OF POSTLISTING MORTALITY AMONG THOSE WITH NORMAL HEIGHT (25-75TH PERCENTILE) AND NONOBESE (BODY MASS INDEX<.001). LVAD PATIENTS HAD A SURVIVABILITY OF 86.1% (95% CI, 80.1-90.5), 88.5% (95% CI, 86.6-90.2), AND 91.2% (95% CI, 89.5-92.7), RESPECTIVELY (LOG-RANK P ¼ .007). BLOOD TYPE O CANDIDATES LISTED WITH THE IMPELLA OR INTRA-AORTIC BALLOON PUMP ARE AT INCREASED RISK OF POST LISTING MORTALITY COMPARED WITH A DURABLE LVAD IN THE CURRENT ORGAN ALLOCATION ERA. THESE EFFECTS ARE DIMINISHED AMONG THOSE WITH NORMAL HEIGHT AND BODY HABITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173565 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death