BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19595865 · Received June 24, 2024

    Report

    Report Number
    2916596-2024-03595
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A3A AND A4; CORRECTED B2: OUTCOMES CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED IMAGING SHOWED EVIDENCE OF A BUILDUP OF BIODEBRIS BETWEEN THE BEND RELIEF AND THE OUTFLOW GRAFT, CONSISTENT WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). REVIEW OF THE SUBMITTED LOG FILES CAPTURED LOW FLOW ALARMS. NO OTHER UNUSUAL EVENTS OR ALARMS WERE CAPTURED. THE SUBMITTED CT IMAGES WERE REVIEWED AND SHOWED CROSS-SECTIONS OF THE OUTFLOW GRAFT. THE IMAGES SHOWED EVIDENCE OF A BUILDUP OF BIODEBRIS BETWEEN THE BEND RELIEF AND THE OUTFLOW GRAFT, CONSISTENT WITH EOGO. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-022275. NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-022275 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK, DOCUMENT 10002833, REV. G ARE CURRENTLY AVAILABLE. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH.". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE LOW FLOW ALARMS OVER SEVERAL DAYS. LOG FILES AND COMPUTED TOMOGRAPHY (CT) SCAN WAS TO BE PERFORMED TO EVALUATE POTENTIAL EXTERNAL OUTFLOW GRAFT OBSTRUCTION (EOGO). THE EOGO WAS CONFIRMED WITH THE CT SCAN. THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED. THE VENTRICULAR ASSIST DEVICE (VAD) SPEED WAS CHANGED FROM 5700 TO 5900. OTHER THAN THE LOW FLOWS, THE PATIENT HAD SYMPTOMS OF DIZZINESS. THE PATIENT WAS REPORTED TO BE IN CHEMOTHERAPY FOR PROSTATE CANCER. DUE TO THE EOGO, THEIR CHEMOTHERAPY WAS PAUSED. THEY WERE BEING TREATED WITH MORE FLUID INTAKE FOR THE LOW FLOES AND THEY WERE TO BE OBSERVED. THE PATIENT WAS REPORTEDLY AT HOME IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182171 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7548511 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R