BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 9255331 · Received October 30, 2019

    Report

    Report Number
    2916596-2019-05013
    Event Type
    Death
    Date Received
    October 30, 2019
    Date of Event
    October 11, 2019
    Report Date
    January 29, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF SUSPECTED THROMBUS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. A CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED ELEVATED LDH, ELEVATED PUMP POWER/FLOW, SUSPECTED THROMBUS, AND LOW FLOW ALARMS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, ALTHOUGH A SPECIFIC CAUSE FOR THE POWER AND FLOW ELEVATIONS CONFIRMED VIA THE SUBMITTED LOG FILES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT BELIEVES THE EVENTS TO BE RELATED TO THE PATIENT¿S AORTIC INSUFFICIENCY. THE ACCOUNT COMMUNICATED THAT THE PATIENT WAS ADMITTED DUE TO ELEVATED LDH WITH TRANSIENT POWER AND FLOW ELEVATIONS. THE ACCOUNT REPORTED THAT THE PATIENT HAD BEEN ADMITTED IN ORDER TO RULE OUT POSSIBLE PUMP THROMBOSIS. A RAMP ECHO WAS PERFORMED WHICH WAS NEGATIVE, BUT THE PATIENT HAS SIGNIFICANT AI. DEVICE THROMBOSIS WAS REPORTEDLY NOT SUSPECTED BY THE ACCOUNT AT THIS TIME AND THE POWER ELEVATIONS WERE BELIEVED TO HAVE BEEN RELATED TO THE PATIENT¿S AI. THE PATIENT WAS LATER BEING WORKED UP FOR TAVR AND HER LDH WAS RISING AGAIN ALONG WITH HER PLASMA FREE HEMOGLOBIN. THE ACCOUNT SUSPECTED PUMP THROMBOSIS AGAIN AND THE PATIENT HAD FLASH PULMONARY EDEMA AND UNDERWENT A COLONOSCOPY AND EGD WITH SUSPECTED ISCHEMIC BOWEL. THE PATIENT UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY ON (B)(6) 2019 WITH PARTIAL GALL BLADDER REMOVAL, LIVER ARC, AND BOWEL RESECTION. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2019 AFTER WITHDRAWAL OF CARE. THE PATIENT¿S OUTCOME WAS NOT BELIEVED TO BE DEVICE RELATED AND THE PUMP WAS OPERATING AS EXPECTED. HEARTMATE II LVAS, WAS NOT EXPLANTED AND WILL NOT BE RETURNING FOR EVALUATION. THE ACCOUNT SUBMITTED LOG FILES FOR REVIEW. THE LOG FILES CAPTURED LOW FLOW HAZARD ALARMS ON (B)(6) 2019 AND (B)(6) 2019 WHEN CALCULATED FLOW DROPPED AS LOW AS 2.3 LPM, BELOW THE LOW FLOW THRESHOLD OF 2.5 LPM. ADDITIONALLY, THE LOG FILES CAPTURED MULTIPLE TRANSIENT ELEVATIONS IN PUMP POWER WITH CORRESPONDING ELEVATIONS IN CALCULATED FLOW. ALSO, THE LOG FILES ALSO CAPTURED A PERIOD OF SUSTAINED ELEVATED POWER ON (B)(6) 2019. CORRESPONDING ELEVATIONS IN CALCULATED FLOW WERE RECORDED DURING THE SUSTAINED PERIOD OF ELEVATED PUMP POWER. OVERALL, PUMP POWER AND CALCULATED FLOW APPEAR TO BE TRENDING UPWARDS TOWARDS THE END OF THE SUBMITTED DATA. OF NOTE, THE MAJORITY OF THESE ELEVATION EVENTS APPEARED TO BE ASSOCIATED WITH PI EVENTS. NO OTHER ATYPICAL ALARMS OR EVENTS WERE CAPTURED, AND THE DEVICE APPEARED TO BE FUNCTIONING AS INTENDED. A DIRECT CORRELATION BETWEEN THE REPORTED POWER/FLOW ELEVATIONS AND ELEVATED LDH AND THE REPORTED SUSPECTED THROMBUS COULD NOT BE DETERMINED. THE HEARTMATE II LVAS IFU LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE HMII IFU PROVIDES DETAILS REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE AS WELL AS OUTLINES INDICATIONS OF PUMP THROMBOSIS AND AS HOW TO RESPOND TO SUCH EVENTS. THE HEARTMATE II LVAS IFU ALSO EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2019. CARE WAS WITHDRAWN AND THE VAD WAS TURNED OFF AT REQUEST OF FAMILY. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED. THE PUMP WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FLASH PULMONARY EDEMA ON (B)(6) 2019. COLONOSCOPY AND EGD WERE CONDUCTED (B)(6) 2019 WITH SUSPECTED ISCHEMIC BOWEL. LACTIC ACID DEHYDROGENASE (LDH) WAS ELEVATED TO 17 ON THE EVENING OF (B)(6) 2019. AN EMERGENT EXPLORATORY LAPAROTOMY WAS PERFORMED ON (B)(6) 2019 WITH PARTIAL GALLBLADDER REMOVAL, LIVER LAC, AND BOWEL RESECTION. LDH MEASURED AT 39 ON (B)(6) 2019. ANALYSIS OF THE LOG FILE CONFIRMED AN UPWARD TREND IN PUMP POWER.

    Additional Manufacturer Narrative · 1

    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 PATIENT WAS ADMITTED ON (B)(6) 2019 WITH INCREASED (LACTATE DEHYDROGENASE) LDH. BASELINE LDH WAS 200 U/L BUT PATIENT PRESENTED WITH LDH OF 755 U/L. PATIENT FELT FATIGUED, SHORT OF BREATH, AND NAUSEATED. PATIENT WAS HEMODYNAMICALLY STABLE. RAMP ECHOCARDIOGRAPHY TEST WAS NEGATIVE BUT THE PATIENT HAD SIGNIFICANT AORTIC INSUFFICIENCY (AI). DEVICE THROMBOSIS WAS NOT SUSPECTED AND POWER SPIKES WERE RELATED TO AI. THE PATIENT WAS WORKED UP FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PATIENT'S LDH CONTINUED TO RISE. ANALYSIS OF THE LOG FILES OVER THE INTERVAL BETWEEN (B)(6) 2019 CONFIRMED OVERALL PUMP POWER AND PULSATILITY INDEX WERE STABLE THROUGHOUT THE COURSE OF THE LOG. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048468 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 5925520 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| L