BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24845047 · Received April 10, 2026

    Report

    Report Number
    2916596-2026-02007
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 31, 2021
    Report Date
    April 10, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVENT DATE JUSTIFICATION UPDATED TO 01AUG2015 AND 31MAR2021. AUTHOR INFORMATION: IYENGAR, A., FEINMAN, J., JIANG, J., SONG, C., KIM, S., MATHEW, A., GOLEC, S., RAO, A., RADAKRISHNAN, A., ASHER, M., REKHTMAN, D., DEPAOLO, J., MOSS, N., ITAGAKI, S., ANYANWU, A., WALD, J., CEVASCO, M., & PARIKH, A. (2025). EPIDEMIOLOGY AND IMPACT OF DEVICE-SPECIFIC INFECTIONS ON PATIENTS RECEIVING LEFT VENTRICULAR ASSIST DEVICES. JHLT OPEN, 8, 100208. HTTPS://DOI.ORG/10.1016/J.JHLTO.2025.100208. CORRESPONDENCE: ADITYA PARIKH, MD, ASSISTANT PROFESSOR OF CLINICAL MEDICINE, DIVISION OF CARDIOVASCULAR MEDICINE, HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA, 3400 CIVIC CENTER BOULEVARD, 2 EAST PAVILION, PHILADELPHIA, PA. E-MAIL ADDRESS: [email protected]. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING INFECTION, STROKE, AND BLEEDING. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. SECTION 6 (UNDER ¿ANTICOAGULATION¿) ALSO PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS NOT BEING PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN "EPIDEMIOLOGY AND IMPACT OF DEVICE-SPECIFIC INFECTIONS ON PATIENTS RECEIVING LEFT VENTRICULAR ASSIST DEVICES" THAT HEARTMATE 3 PATIENTS WERE INVOLVED IN ADVERSE EVENTS. THE RETROSPECTIVE COHORT STUDY EVALUATED ALL PATIENTS WHO UNDERWENT PRIMARY IMPLANTATION OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) BETWEEN 01AUG2015 AND 31MAR2021 AT 2 ACADEMIC HOSPITALS¿THE UNIVERSITY OF PENNSYLVANIA AND MOUNT SINAI HEALTH SYSTEMS. THE STUDY SOUGHT TO EVALUATE THE INCIDENCE, EPIDEMIOLOGY, AND MORBIDITY ASSOCIATED WITH LVAD-SPECIFIC INFECTIONS (LSIS) IN PATIENTS IMPLANTED WITH MODERN CENTRIFUGAL LEFT VENTRICULAR ASSIST DEVICES ACROSS 2 TERTIARY CARE LVAD CENTERS. LSI WAS DEFINED AS DRIVELINE INFECTION, POCKET INFECTION, OR DEVICE INFECTION THAT WAS CULTURE-POSITIVE AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. PATIENTS WERE STRATIFIED INTO 2 GROUPS BASED ON WHETHER THEY DEVELOPED AN LSI DURING THE FOLLOW-UP PERIOD. FROM AUGUST 2015 TO MARCH 2021, 206 PATIENTS WERE IMPLANTED WITH THE HEARTMATE 3 AT THE 2 STUDY CENTERS, OF WHICH 71 (34.5%) DEVELOPED AN LSI. 70 OF THE INFECTIONS WERE MICROBIAL AND ONE WAS FUNGAL. ADDITIONALLY, 1% OF THE LSI INFECTIONS WERE NOTED TO BE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). OF THE 71 LSI PATIENTS, 3 UNDERWENT DEBRIDEMENT AND A DEVICE EXCHANGE, 14 UNDERWENT HEART TRANSPLANT, AND 17 UNDERWENT DEBRIDEMENT. OF THE 17 DEBRIDEMENT'S, 3 ALSO UNDERWENT HEART TRANSPLANT. COMPLICATIONS OF THE INFECTIONS INCLUDED 5 BLOODSTREAM INFECTIONS, 9 EVENTS OF MEDIASTINITIS, 12 POCKET INFECTIONS, AND 55 PATIENTS REQUIRED SUPPRESSIVE ANTIMICROBIAL THERAPY. 53 PATIENTS WERE HOSPITALIZED FOR LSI. THERE WERE 69 REPORTED GASTROINTESTINAL (GI) BLEEDS AND 30 CEREBRAL VASCULAR ACCIDENT (CVA) EVENTS. OF THE PATIENTS WHO DID NOT EXPERIENCE LSI, 3 HAD PUMP EXCHANGES, AND 29 UNDERWENT HEART TRANSPLANTS. OF THE 46 PATIENTS WHO UNDERWENT HEART TRANSPLANTS, THERE WERE 4 HEART TRANSPLANT REJECTIONS AND 5 GRAFT REJECTIONS. OF THE TOTAL PATIENTS, THERE WERE 54 REPORTED PATIENT'S DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905273 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| L