BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15230086 · Received August 15, 2022

    Report

    Report Number
    2916596-2022-12680
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 29, 2022
    Report Date
    March 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EXTRINSIC OUTFLOW GRAFT (OFG) OBSTRUCTION WAS CONFIRMED THROUGH EVALUATION OF THE SUBMITTED COMPUTED TOMOGRAPHY (CT) SCANS. A SPECIFIC CAUSE FOR THE REPORTED OBSTRUCTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORTED INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED SYSTEM CONTROLLER EVENT LOG FILES REVEALED A SMALL DECREASE IN FLOW OVER TIME AND CAPTURED A TRANSIENT LOW FLOW ALARM ON (B)(6) 2022. OF NOTE, ELEVATED PULSATILITY INDEX (PI) VALUES WERE CAPTURED DURING THE LOW FLOW. NO OTHER NOTABLE ALARMS OR EVENTS WERE CAPTURED. THE PUMP APPEARED TO OPERATE AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND CAUTIONS THE USER NOT TO ROTATE/TWIST THE GRAFT. THE IFU 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. THE IFU LISTS DRIVELINE INFECTION AND HYPERTENSION AS ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. THE IFU ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL OCCUR WHEN THE ESTIMATED PUMP FLOW IS BELOW THE LOW FLOW LIMIT AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE IFU AND PATIENT HANDBOOK DESCRIBE ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED, INCLUDING PACKAGING AND STERILIZATION DOCUMENTATION, AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICLE ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS DRIVELINE INFECTION AND HYPERTENSION AS ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 4, ¿SYSTEM MONITOR,¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM OCCURS WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM). A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION. SECTION 5, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. THIS SECTION 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 6, ¿PATIENT CARE AND MANAGEMENT,¿ STATES THAT ¿POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MM HG SHOULD BE CONSIDERED ADEQUATE.¿. SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ EXPLAINS ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK ALSO OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. 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 BROUGHT TO THE EMERGENCY DEPARTMENT TODAY FOR A COMPUTERIZED TOMOGRAPHY (CT) SCAN ON THE DRIVELINE AND CHEST. THE PATIENT REPORTEDLY HAD A DRIVELINE INFECTION. THE CT RESULTS SHOWED A THIN ECCENTRIC THROMBUS WITHIN THE PROXIMAL OUTFLOW CANNULA WITH NO OCCLUSION. THERE WERE NO OTHER ALARMS REPORTED AT THE TIME. THE LOG FILE REVIEW SHOWED PULSATILITY INDEX (PI) EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES. ADDITIONALLY THE LOG CONTAINED 2 UNSUSTAINED LOW FLOW ESTIMATES ON (B)(6) 2022 @ 4:12PM. THESE FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EQUIPMENT MALFUNCTION AND APPEARED PHYSIOLOGICAL IN NATURE. THE PATIENT UNDERWENT AN IVUS (INTRAVASCULAR ULTRASOUND) PROCEDURE ON (B)(6) 2022 TO ASSESS FOR EXTERNAL COMPRESSION OF THE OUTFLOW GRAFT (OFG) VERSUS OFG THROMBUS. IVUS PROCEDURE CONFIRMED EXTERNAL COMPRESSION OF THE OFG; NO OFG THROMBUS. THE CLINICIANS PLANNED TO STENT THE PATIENT'S OFG. IT WAS LATER COMMUNICATED THAT THE PATIENT'S DRIVELINE INFECTION WAS NOTED TO BE P. VULGARIS AND STREPTOCOCCUS CONSTELLATUS WITH ABDOMINAL PAIN, PURULENT AND REDDISH DRAINAGE FROM THE EXIT SITE. THE PATIENT UNDERWENT A DRIVELINE RELOCATION AND DEBRIDEMENT AND WAS GIVEN INTRAVENOUS ANTIBIOTICS TO TREAT THE INFECTION. A WOUND VAC WAS ALSO PLACED ON THE PATIENT DURING THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OUTFLOW GRAFT (OFG) STENT PLACEMENT ON THE MORNING OF (B)(6) 2022. INOTROPES WERE INITIATED FOR THE PROCEDURE. TWO STENTS WERE DEPLOYED IN THE OFG AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING POST-PROCEDURE. THE LOW FLOWS WERE DETERMINED TO BE PARTIALLY DUE TO THE OFG OBSTRUCTION. THE LOW FLOWS DID NOT RESOLVE AS THE PATIENT WAS HYPERTENSIVE BUT WAS OTHERWISE ASYMPTOMATIC. ANTI-HYPERTENSION MEDICATION WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155746 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7728260 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| L