BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21596563 · Received March 13, 2025

    Report

    Report Number
    2916596-2025-01517
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    January 1, 2025
    Report Date
    April 17, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS 01JAN2025, THE DATE OF PUBLICATION, AS NO IMPLANTATION INFORMATION WAS PROVIDED. ZOOK, S., YOUKER, K., INGRAM, K., SAEED, M., OJUKWU, O., AVENATTI, E., LEGHA, S., YOUSEFZAI, R., KIM, J., HUSSAIN, I., MARTIN, C., GORTHI, J., AHSAN, S., FIDA, N., BHIMARAJ, A., GUHA, A., SHANNON, W., MORENO, M., & KASSI, M. (2025). THE ROLE OF ANGIOGENESIS IN GASTROINTESTINAL BLEEDING IN LEFT VENTRICULAR ASSISTED DEVICE PATIENTS: HIGHLIGHTING PLATELET-DERIVED GROWTH FACTOR AS A PREDICTIVE MARKER. JOURNAL OF CARDIAC FAILURE, 31(1), 218. HTTPS://DOI.ORG/10.1016/J.CARDFAIL.2024.10.100. HOUSTON METHODIST DEBAKEY HEART & VASCULAR CENTER, HOUSTON METHODIST, HOUSTON, TX. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING 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 ¿THE ROLE OF ANGIOGENESIS IN GASTROINTESTINAL BLEEDING IN LEFT VENTRICULAR ASSISTED DEVICE PATIENTS: HIGHLIGHTING PLATELET-DERIVED GROWTH FACTOR AS A PREDICTIVE MARKER¿ IDENTIFYING THAT HM3 MAY BE RELATED TO GI BLEEDING. GASTROINTESTINAL BLEEDING (GIB) IS A SIGNIFICANT COMPLICATION AFFECTING UP TO 40% OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) RECIPIENTS. THE STUDY AIMS TO UNDERSTAND THE PATHOPHYSIOLOGY OF GIB IN LVAD PATIENTS WITH AND WITHOUT GIB BY MEASURING SERUM LEVELS OF 15 DIFFERENT ANGIOGENESIS FACTORS. THE STUDY ENROLLED 49 LVAD PATIENTS (AVERAGE AGE 64 YEARS, 39 MALES). BLOOD SAMPLES WERE COLLECTED TO INVESTIGATE THE LEVELS OF ANGIOGENESIS FACTORS ASSOCIATED WITH GIB USING MULTIPLEX ASSAYS. BASELINE DATA WAS GATHERED FOR ALL PARTICIPANTS, ENCOMPASSING DEMOGRAPHIC DETAILS, CLINICAL OUTCOMES, AND DURATION OF LVAD SUPPORT. THE PRIMARY OUTCOME OF INTEREST WAS THE OCCURRENCE OF ANY BLEEDING EVENTS, EVALUATED USING THE AREA UNDER THE RECEIVER OPERATING CHARACTERISTIC (ROC) CURVE. OUT OF 49 LVAD PATIENTS, 24 EXPERIENCED BLEEDING EVENTS. AMONG THE 15 ANGIOGENESIS FACTORS ANALYZED, ONLY 6 YIELDED MEASURABLE RESULTS: EPIDERMAL GROWTH FACTOR (EGF), HEPATOCYTE GROWTH FACTOR (HGF), PLATELET-DERIVE GROWTH FACTOR-BB (PDGF-BB), TUMOR NECROSIS FACTOR ALPHA (TNF-A), VASCULAR ENDOTHELIAL GROWTH FACTOR A (VEGF-A), AND TRANSFORMING GROWTH FACTOR BETA 1 (TGF-B1). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN THE LEVELS OF MOST OF THE ANGIOGENESIS FACTORS BETWEEN BLEEDERS AND NON-BLEEDERS, EXCEPT FOR PDGF-BB, WHICH WAS SIGNIFICANTLY ELEVATED IN PATIENTS WHO EXPERIENCED BLEEDING EVENTS, COMPARED TO THOSE WHO DID NOT. THE STUDY IDENTIFIES PDGF-BB LEVELS AS A SIGNIFICANT PREDICTIVE MARKER FOR GASTROINTESTINAL BLEEDING IN LVAD PATIENTS, DISTINGUISHING BLEEDERS FROM NON-BLEEDERS. THIS HIGHLIGHTS THE POTENTIAL OF TARGETING ANGIOGENESIS PATHWAYS IN MANAGING AND PREDICTING BLEEDING COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823980 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening