BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21447870 · Received February 24, 2025

    Report

    Report Number
    2916596-2025-00850
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    May 1, 2024
    Report Date
    February 24, 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 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 B3: DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION (01MAY2024) AS THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: MODY, K., WALTERS, P., STEWART, S., SILVA, C., LANDERS, D., DUDIY, Y., BATSIDES, G., & ANDERSON, M. (2024). APPLICATIONS OF THE IMPELLA RP FLEX: SINGLE CENTER EXPERIENCE. ASAIO JOURNAL, 70, 159. HTTPS://DOI.ORG/10.1097/MAT.0000000000002073. HACKENSACK UNIVERSITY MEDICAL CENTER, HACKENSACK, NJ. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), DOCUMENT, AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS THE ADVERSE EVENTS, INCLUDING INFECTION, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. 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 ¿APPLICATIONS OF THE IMPELLA RP FLEX: SINGLE CENTER EXPERIENCE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RIGHT VENTRICULAR FAILURE, PNEUMONIA AND DEATH. IMPELLA RP FLEX WAS EVALUATED FOR HEMODYNAMIC AND QUALITY MEASURES. 8 PATIENTS WERE IMPLANTED WITH THE RP FLEX: 1 FOR RIGHT VENTRICULAR (RV) PROPHYLAXIS IN MITRAL SURGERY, 1 FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, 3 FOR PERI-DURABLE VENTRICULAR ASSIST DEVICE FOR RIGHT VENTRICULAR DYSFUNCTION, 1 FOR POST CARDIOTOMY SHOCK FOLLOWING WEANING FROM EXTRACORPOREAL MEMBRANE OXYGENATION, 1 FOR BI-IMPELLA SUPPORT POST CORONARY ARTERY BYPASS GRAFT AND 1 FOR CARDIOMYOPATHY AND CARDIOGENIC SHOCK (CGS) WITH BIVENTRICULAR FAILURE. 3 OF THE 8 PATIENTS HAD REDUCED EJECTION FRACTION REQUIRING CONCOMITANT LEFT VENTRICULAR SUPPORT WITH A HM3. 4 OUT OF 8 PATIENTS HAD PRE-EXISTING GROUP 2 PULMONARY HYPERTENSION WITH MEAN PULMONARY ARTERIAL PRESSURE (PAP) OF 43 MMHG. MEAN PULMONARY ARTERY PULSATILITY INDEX AT BASELINE WAS 1.45, AND MEAN PAP FOR ALL PATIENTS WAS 37 MMHG. MEAN AGE WAS 63.4 YEARS AND 4 PATIENTS WERE FEMALE. 6 OUT OF 8 PATIENTS WERE ABLE TO PARTICIPATE IN PHYSICAL THERAPY WITHIN THE FIRST WEEK POST OPERATIVELY AND WERE OUT OF BED TO A CHAIR IN 2.7 DAYS. NONE OF THE PATIENTS REQUIRED RENAL REPLACEMENT THERAPY DURING DEVICE SUPPORT BUT 1 PATIENT RECEIVED RENAL REPLACEMENT THERAPY 3 WEEKS POST EXPLANT FOR FLUID MANAGEMENT. ONLY 1 PATIENT HAD PROLONGED INTUBATION DUE TO PNEUMONIA. MEAN DAYS ON RP FLEX SUPPORT WAS 4.8 DAYS (1-8 DAYS). NONE OF THE PATIENT¿S REQUIRED LONGSTANDING INOTROPES AND 4 OUT OF 8 PATIENTS REQUIRED SILDENAFIL AT DISCHARGE, AND 2 OUT OF 8 REQUIRED SILDENAFIL AT 30 DAYS POST DISCHARGE. 6 PATIENTS WERE SUCCESSFULLY DISCHARGED WITH MEAN POSTOPERATIVE LENGTH OF STAY (LOS) OF 21.7 DAYS, 13-DAY (8-16 DAYS) MEAN LOS FOR PATIENTS WITH PROPHYLACTIC RP FLEX AND MEAN LOS FOR RIGHT VENTRICULAR RESCUE PATIENTS OF 22.5 DAYS (8-53 DAYS). ONE PATIENT EXPIRED DUE TO BIVENTRICULAR FAILURE AND CGS WHILE 1 PATIENT REMAINED HOSPITALIZED. THE RP FLEX IS AN INTRACORPOREAL RV ASSIST DEVICE THAT ALLOWS FOR RV UNLOADING IN THOSE PATIENTS WHO REQUIRE SHORT TERM RV SUPPORT. IT IS BEST USED EARLY OR IN A PROPHYLACTIC SETTING, ALLOWING FOR STABLE HEMODYNAMICS IN CASES THAT WOULD OTHERWISE REQUIRE HIGH DOSE PRESSORS AND PROLONGED ICU CARE. APPROPRIATE USE OF THE RP FLEX OFFERS PATIENTS WHO OTHERWISE BE TOO HIGH RISK A CHANCE FOR RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375100 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H