BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15917774 · Received December 5, 2022

    Report

    Report Number
    2916596-2022-15238
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    June 15, 2022
    Report Date
    December 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON MLP (B)(6) WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023492 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD STANDING LABS DRAWN DURING OUTPATIENT CLINIC VISIT. HEMOGLOBIN (HGB) RESULTED AS 6.1. THE PATIENT DID NOT REPORT ANY SIGNS OF BLEEDING EXCEPT FATIGUE. THE PATIENT WAS ADMITTED TO A HOSPITAL. BLOOD TRANSFUSION WAS REQUIRED AS WELL AS COLONOSCOPY, AND ESOPHAGOGASTRODUODENOSCOPY (EGD).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATED THAT BLEEDING WAS CONFIRMED. ANEMIA WAS LIKELY MULTIFACTORIAL, HOWEVER THERE WAS EVIDENCE OF REMOTE BLEEDING IN GASTRIC FUNDUS/BODY WITH HEME NOTED WITH PETECHIAL HEMORRHAGES. THERE WAS ALSO A SALMON-COLORED PATCH AT 20 CM AND IRREGULAR Z LINE. DUODENAL MUCOSA WAS UNREMARKABLE. THE PATIENT WAS RECOMMENDED ACID SUPPRESSION WITH A PROTON PUMP INHIBITOR, 40 MG ORALLY DAILY. PATIENT'S DIET WAS NORMAL. IT WAS ALSO RECOMMENDED FOR H.PYLORI STOOL TEST, TO RESUME WARFARIN, TO REPEAT ESOPHAGOGASTRODUODENOSCOPY (EGD) ONCE ABLE TO SAFELY BE OFF OF ANTICOAGULATION TO BIOPSY THE COLORED PATCH NOTED IN THE ESOPHAGUS, AND TO AVOID NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THE PATIENT HAS CONTINUED TO BE ANEMIC WITHOUT SIGNS OR SYMPTOMS OF BLEEDING OR HOSPITALIZATIONS. IRON STUDIES WERE DONE WITH IRON SATURATIONS OF 4. THE PATIENT RECEIVED 2 DOES OF INJECTAFER AND HEMOGLOBIN IMPROVED FROM 8.1 TO 12.2 IN THE MONTH AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625394 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7670613 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention| H