BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21233800 · Received January 24, 2025

    Report

    Report Number
    2916596-2025-00433
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    August 1, 2022
    Report Date
    February 4, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. B3: DATE OF EVENT HAS BEEN ENTERED AS 01AUG2022 AS THE IMPLANT DATE OCCURRED BETWEEN AUGUST 2017 AND AUGUST 2022. B5: DEVICE WAS IMPLANTED AT TIME OF EVENT. 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. RAMOS, J. O., FLETCHER, R., ISLAM, R., MEHTA, A., FERRELL, B., DIEZ-LOPEZ, C., ROCHLANI, Y., MADAN, S., MURTHY, S., SHIN, J., VUKELIC, S., FOREST, S., SIMS, D., PATEL, S., JORDE, U., GOLDSTEIN, D., & SAEED, O. (2024). DAYS ALIVE OUT OF THE HOSPITAL AFTER PLACEMENT OF A CONTEMPORARY LEFT VENTRICULAR ASSIST DEVICE AND HEART TRANSPLANTATION. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S231-S232. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.1109 MONTEFIORE MEDICAL CENTER, BRONX, NY; ALBERT EINSTEIN COLLEGE OF MEDICINE, ALBERT EINSTEIN COLLEGE OF MEDICINE, BRONX, NY; JACOBI MEDICAL CENTER/ ALBERT EINSTEIN COLLEGE OF MEDICINE, BRONX, NY; BELLVITGE UNIVERSITY HOSPITAL, BARCELONA, SPAIN. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF WI (B)(4)). NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    E1; REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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 TITLED ¿DAYS ALIVE OUT OF THE HOSPITAL AFTER PLACEMENT OF A CONTEMPORARY LEFT VENTRICULAR ASSIST DEVICE AND HEART TRANSPLANTATION¿ THAT HEARTMATE 3 (HM3) IMPLANT WAS ASSOCIATED WITH OUTCOMES SUCH AS HEART TRANSPLANT, PUMP DECOMMISSION, OR DEATH. THE HOSPITALIZATION BURDEN OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENTS COMPARED TO HEART TRANSPLANTATION (HT) WAS UNKNOWN SO A SINGLE CENTER, RETROSPECTIVE COHORT STUDY WAS CONDUCTED. ALL CONSECUTIVE PATIENTS GREATER THAN 18 YEARS OLD AND RECEIVING HM3 OR HT FROM AUGUST 2017 TO AUGUST 2022 WERE INCLUDED EXCEPT FOR THOSE WHO DID NOT SURVIVE THEIR INDEX HOSPITALIZATION. TO REDUCE CENSORING BIAS, PATIENTS BRIDGED TO HEART TRANSPLANTATION (BTT) OR DECOMMISSIONED LESS THAN 1 YEAR AFTER HM 3 PLACEMENT WERE ALSO EXCLUDED. DAYS ALIVE OUT OF THE HOSPITAL (DAOH) AT 1-YEAR WERE COLLECTED AFTER DISCHARGE AND COMPARED BETWEEN PATIENTS THAT RECEIVED HM 3 AND HT. OUTPATIENT ENCOUNTERS FOR INVASIVE PROCEDURES WERE CONSIDERED AS TIME SPENT IN THE HOSPITAL. OVERALL, 255 PATIENTS (AGE: 57, IQR: 48-64 YEARS, 27% FEMALE) COMPRISED THE STUDY COHORT. THESE PATIENTS SPENT 351, IQR: 335-358 DAOH AT 1 YEAR AFTER INDEX DISCHARGE. FIFTEEN PATIENTS CROSSED OVER TO HT AFTER 1 YEAR. A TOTAL OF 78 PATIENTS UNDERWENT HM3 IMPLANTATION AND 192 RECEIVED HT. DAOH AT 1 YEAR WERE HIGHER FOR PATIENTS WITH HM3 (357, IQR: 329-364 DAYS) COMPARED TO HT (350, IQR: 336-356 DAYS, P=0.0016). FINDINGS REMAINED SIMILAR AFTER EXCLUDING CROSSOVERS, HM3: 357, IQR: 329-364 DAYS VERSUS HT: 350, IQR: 337-356 DAYS, P < 0.01. LENGTH PER ENCOUNTER WAS SIMILAR FOR HM3 (3, IQR: 1-8 DAYS) VS. HT (1.5, IQR: 1-3 DAYS, P=0.16). OVER 95% OF THE DAYS WERE SPENT OUT OF THE HOSPITAL AFTER EITHER HM 3 OR HT DURING THE FIRST YEAR FOLLOWING DISCHARGE FROM THE INDEX HOSPITALIZATION. PATIENTS RECEIVING HM3 SPENT MORE DAYS OUT OF THE HOSPITAL IN COMPARISON TO HT AT 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017156 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R