BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 25126951 · Received May 8, 2026

    Report

    Report Number
    2916596-2026-02353
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    December 18, 2024
    Report Date
    May 8, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 18DEC2024, SAME AS PUBLISHED DATE SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. 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: IMAOKA, S., KASHIYAMA, N., YOSHIOKA, D., SAITO, S., KAWAMURA, T., KAWAMURA, A., MATSUURA, R., MISUMI, Y., TODA, K., & MIYAGAWA, S. (2024). CLINICAL OUTCOMES OF MODIFIED LEFT VENTRICULAR ASSIST DEVICE DRIVELINE MANAGEMENT. JOURNAL OF ARTIFICIAL ORGANS, 28(2), 207¿¿¿215. HTTPS://DOI.ORG/10.1007/S10047-024-01482-8 OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, JAPAN. MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 ¿CLINICAL OUTCOMES OF MODIFIED LEFT VENTRICULAR ASSIST DEVICE DRIVELINE MANAGEMENT¿ THAT THAT HM3 AND HMII PATIENTS EXPERIENCED DRIVELINE INFECTION. THIS IS A RETROSPECTIVE STUDY EVALUATED THE EFFICACY OF MODIFIED DRIVELINE MANAGEMENT COMPARED WITH THAT OF CONVENTIONAL DRIVELINE MANAGEMENT AND ASSESSED THE OUTCOMES OF 262 PATIENTS WHO UNDERWENT CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION BETWEEN JAN2005 AND MAR2023 AT OSAKA UNIVERSITY IN JAPAN. AMONG THESE PATIENTS, 224 PATIENTS WERE PERFORMED THE CONVENTIONAL DRIVELINE MANAGEMENT AND 38 PATIENTS WERE PERFORMED THE MODIFIED FIXATION METHOD. THE EFFECTIVENESS OF THE MODIFIED DRIVELINE MANAGEMENT WAS EVALUATED IN COMPARISON WITH THE CONVENTIONAL DRIVELINE MANAGEMENT. THE MEAN FOLLOW-UP DURATION WAS 854 ± 648 DAYS. ALL FOLLOW-UP EXAMINATIONS WERE COMPLETED ON 31JUL2023. THE MEAN AGE OF THE PATIENTS WAS 47 (35¿56) YEARS, AND 181 (69%) WERE MEN. LVAD DRIVELINE INFECTION OCCURRED IN 72 PATIENTS DURING FOLLOW-UP. THE PATIENTS WITH MODIFIED FIXATION METHOD WERE OLDER THAN THE PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT (46 (33¿55) VS. 53 (44¿57) YEARS OLD, P < 0.01). REGARDING OF INTERMACS PROFILE, THERE ARE MORE PATIENTS OF PROFILE II IN THE PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT AND MORE PATIENTS OF PROFILE IV IN THE PATIENTS WITH MODIFIED FIXATION METHOD (PROFILE II: 75[33%] VS 6[16%], P = 0.03, PROFILE IV: 11[5%] VS 6[16%], P = 0.02). THE DEVICE TYPE IN PATIENTS WITH MODIFIED FIXATION METHOD WAS ALMOST HEARTMATE 3 AND THE DEVICE TYPE IN PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT WAS ALMOST HEARTMATE II AND OTHER DEVICES (HEARTMATE II: 79 [35%] VS 0 [0%], P < 0.01, HEARTMATE 3: 11 [5%] VS 32 [84%], P < 0.01, OTHER DEVICES: 134 [60%] VS 6 [16%]). THE FINDINGS SHOWED THE RATES OF FREEDOM FROM LVAD DRIVELINE INFECTION IN PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT WERE 86, 75, AND 63% AT 1, 2, AND 3 YEARS AFTER LVAD IMPLANTATION, RESPECTIVELY. MEANWHILE, THE RATE OF FREEDOM FROM LVAD DRIVELINE INFECTION IN PATIENTS MANAGED WITH THE MODIFIED FIXATION METHOD WAS 91% AT 1, 2, AS WELL AS 3 YEARS AFTER LVAD IMPLANTATION. THE MODIFIED FIXATION METHOD SIGNIFICANTLY REDUCED THE OCCURRENCE OF LVAD DRIVELINE INFECTION, COMPARED WITH CONVENTIONAL DRIVELINE MANAGEMENT (P = 0.04). IT WAS OBSERVED NO SIGNIFICANT DIFFERENCE IN THE PATIENT BACKGROUND BETWEEN THE PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT AND THE MODIFIED FIXATION METHOD AFTER THE PROPENSITY SCORE MATCHING REGARDING AGE, BMI, PREOPERATIVE ALBUMIN AND PREOPERATIVE INCIDENCE OF DIABETES MELLITUS. THE RATES OF FREEDOM FROM LVAD DRIVELINE INFECTION IN PATIENTS WITH CONVENTIONAL DRIVELINE MANAGEMENT AFTER THE PROPENSITY SCORE MATCHING WERE 87, 71, AND 57% AT 1, 2, AND 3 YEARS AFTER LVAD IMPLANTATION, RESPECTIVELY. MEANWHILE, THE RATE OF FREEDOM FROM LVAD DRIVELINE INFECTION IN PATIENTS MANAGED WITH THE MODIFIED FIXATION METHOD AFTER THE PROPENSITY SCORE MATCHING WAS 90% AT 1, 2, AS WELL AS 3 YEARS AFTER LVAD IMPLANTATION. THE MODIFIED FIXATION METHOD SIGNIFICANTLY REDUCED THE OCCURRENCE OF LVAD DRIVELINE INFECTION, COMPARED WITH CONVENTIONAL DRIVELINE MANAGEMENT (P = 0.04; FIG. 4). LVAD DRIVELINE INFECTION WAS OBSERVED IN THREE PATIENTS AFTER THE APPLICATION OF THE MODIFIED FIXATION METHOD OF LVAD DRIVELINE. THE PATHOGENIC BACTERIA WERE METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS IN TWO CASES AND METHICILLIN-RESISTANT S. AUREUS IN ONE CASE. DRAINAGE THERAPY, INCLUDING WOUND DEBRIDEMENT, NEGATIVE-PRESSURE WOUND THERAPY, AND ANTIBIOTIC TREATMENT, WAS PERFORMED IN ALL CASES. IN TWO CASES, THE RECURRENCE WAS NOT OBSERVED AFTER THE TREATMENT FOR LVAD DRIVELINE INFECTION. IN THESE CASES, THE INFECTION SPREAD FROM THE LVAD DRIVELINE EXIT SITE, AND THE WOUND WAS DEBRIDED FROM THE LVAD DRIVELINE EXIT SITE. AFTER THE WOUND CULTURE TURNED NEGATIVE, THE LVAD DRIVELINE WAS REPOSITIONED AT THE NEW LVAD DRIVELINE EXIT SITE AND FIXED USING THE MODIFIED FIXATION METHOD. CULTURES FROM THE NEW DRIVELINE EXIT SITE AND DEBRIDED WOUND REMAINED NEGATIVE, AND THE WOUND CLOSED. THE TWO PATIENTS HAD NO RECURRENCE OF LVAD DRIVELINE INFECTION FOR 484 AND 677 DAYS, RESPECTIVELY. IN THE OTHER CASE, THE RECURRENCE OF LVAD DRIVELINE INFECTION WAS OCCURRED AFTER THE TREATMENT FOR LVAD DRIVELINE INFECTION. IN THIS CASE, THE INFECTION SPREAD TO THE SUBCUTANEOUS LVAD DRIVELINE AROUND THE UMBILICUS, AND THE WOUND WAS DEBRIDED. THE WOUND CULTURE AFTER DEBRIDEMENT REMAINED POSITIVE, AND NEGATIVE PRESSURE WOUND THERAPY AND ANTIBIOTIC TREATMENT WERE CONTINUED AFTER HOSPITAL DISCHARGE. THE LVAD DRIVELINE INFECTION RECURRED 2 MONTHS AFTER DISCHARGE FROM THE HOSPITAL. PUS WAS OBSERVED IN THE WOUND AROUND THE UMBILICUS. SUBSEQUENTLY, THE WOUND WAS DEBRIDED AGAIN. HOWEVER, THE INFECTION SPREAD TO THE LVAD DRIVELINE NEAR THE PUMP BODY, AND AN LVAD PUMP EXCHANGE WAS FINALLY PERFORMED. IT WAS CONCLUDED THAT THE MODIFIED FIXATION METHOD OF THE LVAD DRIVELINE MAY OFFER THE POSSIBILITY OF PREVENTING LVAD DRIVELINE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245149 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) Ventricular (assist) bypass DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

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