BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 14408263 · Received May 16, 2022

    Report

    Report Number
    2916596-2022-10920
    Event Type
    Death
    Date Received
    May 16, 2022
    Date of Event
    May 2, 2022
    Report Date
    July 27, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF AN OUTFLOW GRAFT OBSTRUCTION WAS CONFIRMED THROUGH THE EVALUATION OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). AN ANALYSIS OF THE LOG FILE PROVIDED BY THE ACCOUNT CONFIRMED LOW FLOW ALARMS. ALTHOUGH A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED, THE OBSERVED GRAFT COMPRESSION COULD HAVE CONTRIBUTED TO THE LOW FLOW ALARMS. LASTLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED ARRHYTHMIA COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES CONFIRMED THE REPORTED LOW FLOW ALARMS. (B)(6) WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) FULLY INTACT. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S INLET PORT. THE SEALED OUTFLOW CONDUIT (OUTFLOW GRAFT, BEND RELIEF AND OUTLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR WAS SUTURED AROUND THE OUTFLOW GRAFT NUT. OF NOTE, THE SEALED INFLOW CONDUIT, OUTFLOW GRAFT, AND BEND RELIEF WERE OBSERVED TO BE FROM THE PATIENT¿S PREVIOUS PUMP ((B)(6), SEE PI-2022-0062451-01). THE OUTFLOW GRAFT BEND RELIEF WAS RETURNED AND SECURED IN PLACE WITH THE BEND RELIEF COLLAR. APPROXIMATELY 3¿ OF ANOTHER BEND RELIEF WAS RETURNED SLIGHTLY OVERLAPPING THE DISTAL END OF THE EXISTING BEND RELIEF. EVALUATION OF THE OUTFLOW GRAFT BEND RELIEF REVEALED A CUT ON THE PROXIMAL PORTION OF THE BEND RELIEF, CONSISTENT WITH THE PROCEDURE TO CUT OPEN THE BEND RELIEF TO REMOVE TISSUE THAT WAS REPORTEDLY COMPRESSING THE OUTFLOW GRAFT. EXAMINATION OF THE OUTFLOW GRAFT FOUND THE GRAFT TO BE COMPRESSED IN THE DIRECTION OF THE GRAFT HARDWARE, RESULTING IN THE GRAFT FOLDING IN ON ITSELF. THE COMPRESSED AREA WAS ADJACENT TO THE CUT IN THE BEND RELIEF. WHILE COMPRESSED, THE GRAFT SHOWED A NARROWING WHEN VIEWING THE LUMEN. BASED ON THE COVERAGE OF THE NORMAL TISSUE INGROWTH ON THE GRAFT EXTERIOR, THE GRAFT APPEARED TO HAVE BEEN DISTORTED FOR AN UNDETERMINED PERIOD OF TIME WHILE THE DEVICE WAS SUPPORTING THE PATIENT. THE OBSERVED GRAFT COMPRESSION COULD HAVE CONTRIBUTED TO REPORTED LOW FLOWS. UPON DISASSEMBLY OF THE RETURNED PUMP, CLOTTED BLOOD WAS OBSERVED THROUGHOUT THE ENTIRE PUMP. THE BLOOD WAS UNSTRUCTURED AND WAS NOT ADHERED TO THE BLOOD-CONTACTING SURFACES. THE DEPOSITIONS APPEARED ACUTE AND CONSISTENT WITH STAGNANT BLOOD IN THE DEVICE FOLLOWING SUPPORT. THE EVALUATION DID NOT REVEAL ANY EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS IN THE DEVICE. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 12OCT2021. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS CARDIAC ARRHYTHMIA AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX ARE ALSO ADDRESSED IN SECTION 1 OF THIS IFU. THE IFU PROVIDES DETAILS ON THE FACTORS THAT AFFECT PUMP FLOW AND PROVIDES INFORMATION ON ASSESSING FLOW. THE IFU EXPLAINS THAT LOW FLOW ALARMS OCCUR WHEN THE ESTIMATED FLOW IS CALCULATED BELOW THE LOW FLOW THRESHOLD OF 2.5 LITERS PER MINUTE (LPM). SECTION 5 "SURGICAL PROCEDURES" PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. THE IFU SPECIFICALLY STATES: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "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. THE LINE SHOULD BE STRAIGHT." ADDITIONALLY, THIS SECTION CAUTIONS THAT THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE. THIS IFU OUTLINES THE INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE IFU ADVISES THE PATIENT TO CHECK THE DRIVELINE FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. LASTLY, THE SECTION ENTITLED "ALARMS AND TROUBLESHOOTING" DESCRIBES ALL ALARM CONDITIONS INCLUDING THE LOW FLOW HAZARD AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE II LVAS PATIENT HANDBOOK, IS ALSO CURRENTLY AVAILABLE. THIS HANDBOOK ALSO CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿ ¿ HOWEVER, ALL HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD) DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE MOVEMENT/FLEXING OVER TIME. THE ¿ALARMS AND TROUBLESHOOTING¿ SECTION OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. THE PATIENT HANDBOOK ALSO CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, FOLLOWING A PUMP EXCHANGE PROCEDURE, THE NEW PUMP STARTED WITH GOOD FLOWS BUT AFTER ABOUT AN HOUR PATIENT DECOMPENSATED WITH SUBSEQUENT LOW FLOW ALARMS AND VENTRICULAR TACHYCARDIA WHICH REQUIRED FURTHER SUPPORT. THE LOG FILES CAPTURES LOW FLOWS AS LOW AS 1.9 LPM AND POWER BETWEEN 3-4 W. LATER THAT DAY, THE PATIENT PASSED AWAY. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE PRE-EXCHANGE PUMP: 2916596-2022-10613.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427952 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 8114818 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R| D