BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9548326 · Received January 3, 2020

    Report

    Report Number
    2916596-2019-06062
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 10, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CAUSE FOR THE REPORTED INFECTION COULD NOT BE DETERMINED. REVIEW OF THE SUBMITTED LOG FILES DID NOT REVEAL ANY SYSTEM CONTROLLER ALARMS. PUMP SPEED REMAINED AT OR ABOVE THE LOW SPEED LIMIT THROUGHOUT THE FILE AND THE DATA APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS HEMOLYSIS AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE CAN ALSO BE FOUND IN THIS DOCUMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B1, B2, B5, H6: ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CAUSE FOR THE REPORTED INFECTION COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE PATIENT OUTCOME WAS DUE TO THE REPORTED INFECTION. REVIEW OF THE SUBMITTED LOG FILES DID NOT REVEAL ANY SYSTEM CONTROLLER ALARMS. PUMP SPEED REMAINED AT OR ABOVE THE LOW SPEED LIMIT THROUGHOUT THE FILE AND THE DATA APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED. ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT'S MOST RECENT LDH WAS 2842. ACCORDING TO THE ACCOUNT, THE PATIENT WAS ON HIGH DOSAGES OF BLOOD PRESSURE SUPPORT MEDICATIONS WITH MARGINAL RIGHT VENTRICULAR FUNCTION. THE PATIENT'S CHEST REMAINED OPEN SINCE EXCHANGE FROM HEARTMATE II (HMII) TO HM3 DUE TO PERSISTENT INFECTION DESPITE ANTIBIOTIC COURSE, REQUIRING SEVERAL WASHOUTS. ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT'S LDH WAS UP TO 3000 DESPITE BEING ON HEPARIN. IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO THE PREVIOUSLY REPORTED PERSISTENT INFECTION. THE DEVICE WAS OPERATING AS INTENDED. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) LISTS HEMOLYSIS, INFECTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE CAN ALSO BE FOUND IN THIS DOCUMENT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2019. THE CURRENT REVISION OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) LISTS INFECTION, HEMOLYSIS, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REFERENCE TO PREVENTING INFECTION ARE PROVIDED THROUGHOUT THIS IFU, INCLUDING SECTIONS TITLED "CARING FOR THE DRIVELINE EXIT SITE" AND "CONTROLLING INFECTION." SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THIS HANDBOOK ALSO CONTAINS INFORMATION ABOUT PREVENTING INFECTION. 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 PASSED AWAY ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT WAS NON-DISCHARGEABLE DUE TO THE TRANSPLANTED INFECTION. THE VAD WAS REPORTED TO BE WORKING AS INTENDED.

    Additional Manufacturer Narrative · 1

    PUMP EXCHANGE ON (B)(6) 2019 WAS REPORTED UNDER MFR# 2916596-2019-05562. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LACTATE DEHYDROGENASE (LDH) WAS 2842 U/L. THE LOG FILE WAS SENT FOR ANALYSIS. CUSTOMER NOTED SPEED ADJUSTMENTS STARTING (B)(6) 2019. AT THE TIME, THERE WAS NO EVIDENCE OF THROMBUS IN THE PUMP. THE DATA SHOWED MULTIPLE PULSATILITY INDEX (PI) EVENTS THAT OCCURRED ON (B)(6) 2019 THROUGH (B)(6) 2019. DOCTOR OF MEDICINE (MD) REPORTED RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WAS EXPLANTED 3 DAYS PRIOR. CONTINUED ON HIGH DOSE DOBUTAMINE (10) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) (3) WITH MARGINAL RIGHT VENTRICULAR (RV) FUNCTION. CHEST REMAINED OPEN DUE TO PERSISTENT INFECTION (REASON FOR HEARTMATE 2 (HM2) TO HEARTMATE 3 (HM3) EXCHANGE ON (B)(6) 2019). MD CONFIRMED NO CHANGES TO LVAD FLOW OR POWER, NO SIGNIFICANT PI EVENTS. WANTED TO RULE OUT THROMBUS IN HM3. AS DISCUSSION NOTES, MADE NOTATION FOR PERSISTENT INFECTION DESPITE HM2 EXPLANT, 3 DAYS RESPITE ON CENTRIMAG (CMAG) WITH OXYGENATOR AND SUBSEQUENT HM3 IMPLANT. DISCUSSION REGARDING PATIENT'S PROGRESS SINCE OPERATING ROOM (OR). HM2 EXPLANTED DUE TO INFECTION. HM3 IMPLANTED WITH RV FAILURE AT TIME OF SURGERY, REQUIRING CMAG. RVAD EXPLANTED ON (B)(6) 2019 (APPROXIMATELY) WITH PERSISTENT RV STRUGGLE. CHEST REMAINED OPEN SINCE (B)(6) 2019 SURGERY, REQUIRING SEVERAL WASHOUTS. LDH ELEVATION 3000 U/L ON (B)(6) 2019, DAY PRIOR WAS 300 U/L DESPITE BEING ON HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7098 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7069098 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H| R