BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20162224 · Received September 6, 2024

    Report

    Report Number
    2916596-2024-05747
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 1, 2023
    Report Date
    November 1, 2024
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PURPOSE OF THIS RESEARCH ARTICLE, ¿SHOULD LIVING ALONE BE AN ABSOLUTE CONTRAINDICATION TO HEARTMATE 3 IMPLANTATION: A SINGLE CENTER EXPERIENCE,¿ WAS TO EVALUATE THE INFLUENCE OF RESIDENCE STATUS (LIVING ALONE VS LIVING WITH CAREGIVER) ON COMPLICATIONS AND SURVIVAL OF HEARTMATE 3 (HM3) PATIENTS AT A HIGH-VOLUME CENTER. A RETROSPECTIVE STUDY WAS CONDUCTED THAT REVIEWED ALL PATIENTS IMPLANTED WITH A HM3 BETWEEN JUN2020 AND AUG2023 AT A SINGLE CENTER. THE PATIENTS¿ BASELINE CHARACTERISTICS, CLINICAL OUTCOMES, RESIDENCE STATUS AND RESPONSIBILITY FOR DRIVELINE MANAGEMENT WERE EXTRACTED FROM ELECTRONIC MEDICAL RECORDS. THE STUDY OUTCOMES INCLUDED SURVIVAL, DRIVELINE INFECTION (DLI), GASTROINTESTINAL BLEEDING (GIB), READMISSION, AND DEATH. AMONG 128 HM3 PATIENTS, 21 (16%) LIVED ALONE AND 107 (84%) LIVED WITH A CAREGIVER. BASELINE CHARACTERISTICS WERE SIMILAR BETWEEN THE TWO GROUPS. DURING THE MEDIAN FOLLOW-UP OF 519 [222-746] DAYS, 5 (4%) PATIENTS DIED, 13 (10%) HAD DLI, 15 (12%) GIB AND 71 (56%) WERE READMITTED. THERE WAS A NUMERICAL TREND TOWARDS WORSE OUTCOMES AMONG PATIENTS LIVING ALONE VS NOT IN THE STUDY OUTCOMES. TWO-YEAR SURVIVAL WAS 82% AMONG PATIENTS LIVING ALONE AND 94% AMONG PATIENTS LIVING WITH CAREGIVER. THE STUDY CONCLUDED THAT LIVING ALONE MIGHT BE ASSOCIATED WITH AN INCREASED RISK OF COMPLICATIONS FOLLOWING HM3 IMPLANTATION, HOWEVER IT SHOULD NOT BE CONSIDERED PROHIBITIVE OF THIS LIFE SAVING THERAPY. HEIGHTENED VIGILANCE AND CARE ARE REQUIRED BY THE MEDICAL TEAMS IN ORDER TO MITIGATE THESE ADVERSE EVENTS. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C AND THE HM 3 LVAS PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS BLEEDING AND INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. ADDITIONALLY, SECTION 6 ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. 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 B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN JUNE 2020 AND AUGUST 2023. LADANYI, A., SHAHIDI, C., CALÌ, F., CAREY, DELUTY, S., MONDELLINI, G., PINSINO, A., FELDMAN, V., SAYER, G., KAKU, Y., URIEL, N., TAKEDA, K., COLOMBO, P., & YUZEFPOLSKAYA, M. (2024). SHOULD LIVING ALONE BE AN ABSOLUTE CONTRAINDICATION TO HEARTMATE 3 IMPLANTATION: A SINGLE CENTER EXPERIENCE. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S541¿S542. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.787 NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "SHOULD LIVING ALONE BE AN ABSOLUTE CONTRAINDICATION TO HEARTMATE 3 IMPLANTATION: A SINGLE CENTER EXPERIENCE,¿ THAT THE HEARTMATE 3 (HM3) MAY BE RELATED TO DEATH, DRIVELINE INFECTION (DLI), AND GASTROINTESTINAL BLEEDING (GIB). A RETROSPECTIVE REVIEW OF ALL PATIENTS IMPLANTED WITH HM3 BETWEEN JUN2020 AND AUG2023 WAS PERFORMED. PATIENTS¿ BASELINE CHARACTERISTICS, CLINICAL OUTCOMES, RESIDENCE STATUS AND RESPONSIBILITY FOR DRIVELINE MANAGEMENT WERE EXTRACTED FROM ELECTRONIC MEDICAL RECORDS. STUDY OUTCOMES INCLUDED SURVIVAL, DLI, GIB AND READMISSION. AMONG 128 HM3 PATIENTS, 21 LIVED ALONE AND 107 LIVED WITH A CAREGIVER. DURING THE MEDIAN FOLLOW-UP OF 519 DAYS, 5 PATIENTS DIED, 13 HAD DLI, 15 GIB AND 71 WERE READMITTED. THERE WAS A NUMERICAL TREND TOWARDS WORSE OUTCOMES AMONG PATIENTS LIVING ALONE VS NOT IN THE STUDY OUTCOMES. 2-YEAR SURVIVAL WAS 82% AMONG PATIENTS LIVING ALONE AND 94% AMONG PATIENTS LIVING WITH CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343936 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R