BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22014410 · Received May 13, 2025

    Report

    Report Number
    2916596-2025-03133
    Event Type
    Death
    Date Received
    May 13, 2025
    Date of Event
    January 1, 2021
    Report Date
    June 24, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 SYSTEMS AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS IN USE WERE NOT PROVIDED. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 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, INCLUDING DEATH. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT IS APPROXIMATE (01JAN2021) AS THE DATA WERE COLLECTED BETWEEN 01JAN2015 TO 01JAN 2021. 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. AUTHOR INFORMATION: JAMES, J. R., FULLER, M., HUNT, M. H., POWELL, E., LU, G., LI, Q., OMARY, A., & HOLLIS, I. B. (2025). HEMOCOMPATIBILITY-RELATED ADVERSE EVENTS ASSOCIATED WITH OR WITHOUT LOW MOLECULAR WEIGHT HEPARIN BRIDGING IN OUTPATIENTS WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE. ARTIFICIAL ORGANS. HTTPS://DOI.ORG/10.1111/AOR.14986. DEPARTMENT OF PHARMACY, UNIVERSITY OF NORTH CAROLINA HOSPITALS, CHAPEL HILL, NORTH CAROLINA, USA / DEPARTMENT OF PHARMACY, WAKEMED HEALTH & HOSPITALS, RALEIGH, NORTH CAROLINA, USA / UNIVERSITY OF NORTH CAROLINA ESHELMAN SCHOOL OF PHARMACY, CHAPEL HILL, NORTH CAROLINA, USA / DEPARTMENT OF PHARMACY, NOVANT HEALTH PRESBYTERIAN MEDICAL CENTER, HUNTERSVILLE, NORTH CAROLINA, USA / DEPARTMENT OF BIOSTATISTICS, UNIVERSITY OF NORTH CAROLINA GILLINGS SCHOOL OF GLOBAL PUBLIC HEALTH, CHAPEL HILL, NORTH CAROLINA, USA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿HEMOCOMPATIBILITY- RELATED ADVERSE EVENTS ASSOCIATED WITH OR WITHOUT LOW MOLECULAR WEIGHT HEPARIN BRIDGING IN OUTPATIENTS WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE¿, THAT THE HM3 MAY BE ASSOCIATED WITH DEATH, BLEEDING, AND THROMBOTIC EVENTS. A SINGLE- CENTER, RETROSPECTIVE, ELECTRONIC MEDICAL RECORD REVIEW OF ALL ADULT PATIENTS WITH A HEARTMATE 3 IMPLANTED FROM 1JAN2015 TO 1JAN 2021 WAS PERFORMED. PATIENTS WERE CATEGORIZED INTO TWO GROUPS: THOSE WHO RECEIVED OUTPATIENT BRIDGING WITH ENOXAPARIN FOR INR VALUES = 1.7 AND THOSE WHO DID NOT. INCLUDED PATIENTS WERE REQUIRED TO BE ON HM3 SUPPORT FOR AT LEAST 18 MONTHS AND WERE EXCLUDED IF THEY DIED PRIOR TO INDEX DISCHARGE, STOPPED WARFARIN FOR > 30 CONSECUTIVE DAYS OF THE FOLLOW- UP PERIOD, HAD AN INR GOAL OTHER THAN 2¿3 OR 2¿2.5, HAD NO RECORDED INR FOR > 90 CONSECUTIVE DAYS, OR HAD A DIAGNOSIS OF HEPARIN-INDUCED THROMBOCYTOPENIA. THE PRIMARY OUTCOME WAS A COMPOSITE OF BLEEDING AND THROMBOTIC EVENTS (HEMOCOMPATIBILITY- RELATED ADVERSE EVENTS [HRAES]) BETWEEN PATIENTS WHO WERE BRIDGED WITH ENOXAPARIN AND THOSE WHO WERE NOT, RANGING IN SEVERITY FROM NUISANCE TO FATAL BLEEDING. BRIDGING OPPORTUNITIES (BOS) WERE DEFINED AS INRS = 1.7. EACH PATIENT COULD CONTRIBUTE MORE THAN ONE BO DURING THE FOLLOW- UP PERIOD. HEMOCOMPATIBILITY- RELATED ADVERSE EVENTS WERE COLLECTED FOR 30 DAYS FOLLOWING THE END OF EACH BO. ONE HUNDRED TWENTY PATIENTS WERE EVALUATED. FIFTY- ONE PATIENTS WERE EXCLUDED, PRIMARILY DUE TO DEATH PRIOR TO INDEX HOSPITAL DISCHARGE OR HAVING THEIR HM3 FOR < 18 MONTHS. THERE WAS AN AVERAGE OF 13 (RANGE 2¿33) BOS PER PATIENT. OF THE INCLUDED PATIENTS, 15 RECEIVED ENOXAPARIN BRIDGING DURING = 1 BO, AND 64 DID NOT. OF THE 1036 TOTAL BOS, ONLY 39 (3.76%) WERE BRIDGED WITH ENOXAPARIN. IN THE BRIDGED GROUP, THERE WERE 39 BOS RESULTING IN NO HRAES, AS COMPARED TO 997 BOS RESULTING IN 12 HRAES (1.20%) IN THE NON- BRIDGED GROUP. OF THE 12 HRAES IN THE NON- BRIDGED GROUP, ONLY 2 (0.2%) WERE THROMBOTIC, BOTH BEING MINOR VENOUS THROMBOEMBOLISMS (VTES). NO EPISODES OF CONFIRMED OR SUSPECTED PUMP THROMBOSIS OR STROKES OCCURRED IN EITHER GROUP. A TOTAL OF 34 BLEEDING EVENTS OF ANY SEVERITY OCCURRED IN THE NON- BRIDGED GROUP (0.034 EVENTS PER BO) AS COMPARED TO 2 IN THE BRIDGED GROUP (0.051 EVENTS PER BO). MAJOR BLEEDING EVENTS IN THE NON- BRIDGED GROUP WERE EITHER GASTROINTESTINAL OR DRIVELINE SITE BLEEDING. BOTH BLEEDING EVENTS IN THE BRIDGED GROUP WERE CLASSIFIED AS TYPE 1 (MINOR BLEEDING). ACROSS BOTH GROUPS, THERE WERE A TOTAL OF 38 HRAES AND A TOTAL OF 0.32 HRAE EVENTS PER PATIENT- YEAR. IN SUMMARY, THE EXCEEDINGLY LOW THROMBOTIC EVENT RATE FOUND IN PATIENTS WITH A HM3 AND LOW RATES OF BACKGROUND ASPIRIN USE WHO WERE NOT BRIDGED WITH ENOXAPARIN DURING PERIODS OF LOW INR CALLS INTO SIGNIFICANT QUESTION THE MERITS OF BRIDGING PATIENTS WITH ENOXAPARIN AS A ROUTINE PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967613 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death