BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21501398 · Received March 2, 2025

    Report

    Report Number
    2916596-2025-01390
    Event Type
    Death
    Date Received
    March 2, 2025
    Date of Event
    January 7, 2021
    Report Date
    March 31, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI NUMBER CORRECTED. E1: CUSTOMER SITE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND REPORTED OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, 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.

    Additional Manufacturer Narrative · 0

    B5: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS: 01JUL2021 AS PATIENTS UNDERWENT HEART OR HEART/KIDNEY TRANSPLANTATION BETWEEN NOV2018 AND JUL2021. DEPARTMENT OF ANESTHESIOLOGY AND PERIOPERATIVE MEDICINE, MAYO CLINIC, JACKSONVILLE, FL, DEPARTMENT OF CRITICAL CARE MEDICINE, MAYO CLINIC, JACKSONVILLE, FL, DIVISION OF CARDIOVASCULAR AND THORACIC ANESTHESIOLOGY, DEPARTMENT OF ANESTHESIOLOGY AND PERIOPERATIVE MEDICINE, MAYO CLINIC, JACKSONVILLE, FL DIVISION OF TRANSPLANTATION AND ADVANCED HEART FAILURE, MAYO CLINIC, JACKSONVILLE, FL, DEPARTMENT OF CARDIOLOGY, OREGON HEALTH AND SCIENCE UNIVERSITY, PORTLAND, OR. SHAPIRO, A. B., FRITZ, A. V., KILEY, S., SHARMA, S., PATEL, P., HECKMAN, A., MARTIN, A. K., & GOSWAMI, R. (2024). COMPARISON OF INTRAOPERATIVE BLOOD PRODUCT USE DURING HEART TRANSPLANTATION IN PATIENTS BRIDGED WITH IMPELLA 5.5 VERSUS DURABLE LEFT VENTRICULAR ASSIST DEVICES. JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA, 38(11), 2567¿2575. HTTPS://DOI.ORG/10.1053/J.JVCA.2024.04.047. 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 90979616). 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. H10: NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿COMPARISON OF INTRAOPERATIVE BLOOD PRODUCT USE DURING HEART TRANSPLANTATION IN PATIENTS BRIDGED WITH IMPELLA 5.5 VERSUS DURABLE LEFT VENTRICULAR ASSIST DEVICES¿ THAT HEARTMATE 3 MAY BE ASSOCIATED WITH STROKE, INFECTION, RV FAILURE, BLEEDING, PUMP THROMBOSIS, TRANSPLANT AND DEATH. INDIVIDUALS WITH DURABLE LVADS ALSO EXPERIENCED HEMATOMA, HEMOLYSIS, AND CONTROLLER FAILURE. THIS WAS A SINGLE-CENTER, RETROSPECTIVE, OBSERVATIONAL STUDY OF PATIENTS WHO UNDERWENT ORTHOTOPIC HEART TRANSPLANT OR COMBINED HEART AND KIDNEY TRANSPLANT FROM NOVEMBER 2018 TO JULY 2021. THE DATA WERE COLLECTED VIA REVIEW OF ELECTRONIC MEDICAL RECORDS. THIS STUDY AIMED TO DETERMINE IF THE INTRAOPERATIVE TRANSFUSION REQUIREMENTS DIFFER BASED ON THE MECHANICAL CIRCULATORY DEVICE USED AS A BRIDGE TO HEART TRANSPLANTATION. 24 PATIENTS WERE BRIDGED WITH IMPELLA 5.5 AND 19 PATIENTS WERE BRIDGED WITH DURABLE LVAD (11 PATIENTS HAD HEARTWARE LVADS, 4 HAD HEARTMATE 2 LVADS AND 4 HAD HEART MATE 3 LVADS.) OF THE 19 DURABLE LVAD PATIENTS IN THE STUDY, 12 WERE TRANSPLANTED AFTER A COMPLICATION SUCH AS THROMBOSIS OR DRIVELINE INFECTION. INCLUSION CRITERIA INCLUDED ALL PATIENTS WHO UNDERWENT ORTHO TOPIC HEART OR HEART/KIDNEY TRANSPLANTATION BETWEEN NOVEMBER 2018 AND JULY2021 BRIDGED TO TRANSPLANTATION WITH EITHER AN IMPELLA 5.5 OR DURABLE LVAD. PATIENTS WHO DID NOT SURVIVE TO HEART TRANSPLANTATION WERE EXCLUDED FROM THE STUDY. OUT OF THE 19 INDIVIDUALS WITH DURABLE LVAD, 1 EXPERIENCED STROKE, 7 HAD INFECTIONS, 3 EXPERIENCED RV FAILURE, 3 EXPERIENCED BLEEDING, AND 2 HAD PUMP THROMBOSIS. MINOR COMPLICATIONS AMONG THE LVAD POPULATION INCLUDED 9 CASES OF HEMATOMA, 4 CASES OF HEMOLYSIS AND 6 CASES OF CONTROLLER FAILURE. THIS STUDY HIGHLIGHTED THE SIGNIFICANT DIFFERENCES IN INTRAOPERATIVE TRANSFUSIONS BETWEEN THE IMPELLA 5.5 AND THE DURABLE LVAD, INCLUDING A REDUCTION IN CRYOPRECIPITATE, AUTOLOGOUS BLOOD TRANSFUSION, AND PLATELETS IN THOSE BRIDGED WITH THE IMPELLA 5.5. IT ALSO FOUND A TREND TOWARD A REDUCTION OF PRBC AND FFP IN THE INTRAOPERATIVE TRANSFUSION REQUIREMENTS OF PATIENTS BRIDGED TO HEART TRANSPLANT WITH AN IMPELLA 5.5 DEVICE VERSUS THOSE BRIDGED USING A DURABLE LVAD. ADDITION ALLY, PATIENTS BRIDGED WITH THE IMPELLA 5.5 HAD SHORTER CPB TIMES AND A LOWER VIS POST HEART TRANSPLANTATION. THE IMPELLA 5.5 AS A TEMPORARY MCS DEVICE MAY OFFER AN ALTERNATIVE PATHWAY COMPARED TO THE TRADITIONAL DURABLE LVAD PLACEMENT AND ASSOCIATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164682 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death