BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15168723 · Received August 4, 2022

    Report

    Report Number
    2916596-2022-12520
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 28, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE: BACTEREMIA (4846). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CAUSE FOR THE PATIENT¿S DRIVELINE INFECTION, BACTEREMIA, AND STERNAL ABSCESS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED BLEEDING AND RIGHT VENTRICLE RUPTURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED OUTFLOW GRAFT RUPTURE WAS CONFIRMED THROUGH THE SUBMITTED PHOTOS; HOWEVER, A DIRECT CAUSE FOR THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT WITH NO FURTHER ISSUES REPORTED AT THIS TIME. REVIEW OF THE AVAILABLE DEVICE HISTORY RECORDS, INCLUDING STERILIZATION AND PACKAGING DOCUMENTATION, SHOWED NO DEVIATIONS FROM MANUFACTURING AND QA (QUALITY ASSURANCE) SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. INFECTION AND BLEEDING ARE LISTED IN THE HEARTMATE 3 LVAS IFU AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE INCLUDED IN SEVERAL SECTIONS OF THE IFU, INCLUDING IN SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "CAUTION!", "CARING FOR THE DRIVELINE EXIT SITE", AND "CONTROLLING INFECTION"). SECTION 6 ALSO PROVIDES SUGGESTED RESPONSES IN THE EVENT OF INFECTION. SECTION 5 OF THIS IFU CONTAINS INSTRUCTIONS FOR UNPACKING THE SEALED OUTFLOW GRAFT (5-15) AND PREPARING THE SEALED OUTFLOW GRAFT (5-16). SECTION 5 ALSO STATES THAT DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. THE HEARTMATE 3 LVAS PATIENT HANDBOOK PROVIDES CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION IN SEVERAL SECTIONS, INCLUDING SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ (UNDER ¿CARING FOR THE DRIVELINE EXIT SITE¿). THE PATIENT HANDBOOK INSTRUCTS THE PATIENT TO CALL THEIR HOSPITAL CONTACT IMMEDIATELY IF ANY SIGNS OF INFECTION ARE NOTICED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE: BACTEREMIA (4846). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH DRIVELINE (DL) INFECTION, NOTED WITH BACTEREMIA, AND WAS TAKEN TO THE OPERATING ROOM (OR) FOR INCISION AND DRAINAGE. THE PATIENT HAD LARGE ABSCESS LOOKING KNOT JUST INFERIOR TO THE OLD STERNAL INCISION SITE. THE SURGEON OPENED UP THE WOUND AND FOUND OLD HEMATOMA WITH PURULENT DRAINAGE AND CLOTS. WHILE REMOVING ONE CLOT CLOSE TO THE OUTFLOW GRAFT (OFG), BRIGHT-RED BLOOD BEGAN FLOODING THE WOUND OPENING. THE SURGEON WAS ABLE TO GET A CLAMP ON THE OFG AND STOP THE BLEEDING AND WENT ONTO CARDIOPULMONARY BYPASS (CPB). ONCE ON CPB, IT BECAME EASIER TO VISUALIZE THE AREA AND IT WAS NOTED THAT THE OFG WAS SITTING ON THE DRIVELINE (DL) AT THE PROXIMAL PORTION OF THE VELOUR. PER THE SURGEON, IT APPEARED THAT THE OFG WAS RUBBING ON THE DL AT THE PROXIMAL JUNCTION OF THE VELOUR AND ERODED A 3CM HOLE INTO THE GRAFT AND THE CLOTS THAT WERE CLOSE-BY WERE TAMPONADING THE HOLE. THE HOLE WAS SUTURED CLOSE IN THE OFG, PERICARDIAL PATCH WAS PLACED BETWEEN THE OFG AND DL TO PREVENT FURTHER RUBBING AND DAMAGE TO THE OFG. THE SURGEON WAS ALSO ABLE TO GRAB SOME OMENTUM AND WRAP AROUND THE DL. THE PATIENT ALSO HAD RIGHT VENTRICULAR RUPTURE AND IT WAS REPAIRED IN THE SAME PROCEDURE. IN THE OPERATING ROOM, THE PATIENT RECEIVED 3 UNITS OF PACKS OF RED BLOOD CELLS (PRBC). ONCE REPAIR WAS DONE, CHEST TUBES WERE PLACED, STERNUM CLOSED, SKIN CLOSED AND TRANSPORTED TO CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) IN STABLE CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICLE WAS FOUND RUPTURED DURING INCISION AND DRAINAGE OF INFECTED DRIVELINE SECONDARY TO STERNAL ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520397 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7845077 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization| R