BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5076652 · Received September 15, 2015

    Report

    Report Number
    2916596-2015-01691
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 17, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT OF ELEVATED LACTATE DEHYDROGENASE WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED LVAD PUMP; HOWEVER, SPECIFIC CAUSES FOR THE REPORTED PUMP POCKET INFECTION AND RENAL FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. EXAMINATION OF THE SEALED OUTFLOW GRAFT REVEALED RED NON-LAMINATED DEPOSITIONS OF TISSUE AND BLOOD SITUATED ON THE TEXTURED BLOOD-CONTACTING SURFACE OF THE GRAFT ATTACHMENT. SIMILAR DEPOSITIONS WERE FOUND IN THE LUMEN OF THE OUTFLOW ELBOW AND ON THE BODY OF THE ROTOR. SPECIFIC CAUSES FOR THEIR DEVELOPMENT CANNOT BE CONCLUSIVELY DETERMINED. THE DEPOSITIONS DID NOT APPEAR TO OCCLUDE THE FLOW OF BLOOD. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD TUBE/ROTOR OUTLET SECTION REVEALED A LARGE NON-LAMINATED DEPOSITION SITUATED ON THE OUTLET BEARING CUP AND THE OUTLET CONE SECTION OF THE ROTOR. THE DEPOSITION APPEARED TO HAVE THE POTENTIAL TO OCCLUDE THE FLOW OF BLOOD THROUGH THE PUMP. THE LACK OF LAMINATED LAYERING INDICATES THAT THE DEPOSITION DID NOT DEVELOP IN THE AREA. ALTHOUGH ITS ORIGIN AND A DURATION OF TIME FOR WHICH IT WAS PRESENT IN THIS AREA CANNOT BE CONCLUSIVELY DETERMINED, THE DEPOSITION APPEARED TO HAVE AREAS THAT APPEARED DENATURED AND THE CONTACT ON THE OUTLET BEARING CUP AND THE OUTLET CONE SECTION OF THE ROTOR, SUGGEST THAT THE DEPOSITION WAS PRESENT WHILE THE PUMP WAS OPERATING. THE DEPOSITIONS FOUND IN THE EVALUATION WOULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. THE DEPOSITION FOUND IN THE BLOOD TUBE/ROTOR OUTLET SECTION WOULD HAVE OCCLUDED THE FLOW OF BLOOD THROUGH THE PUMP, POTENTIALLY CONTRIBUTING TO THE REPORTED LOW VAD FLOWS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE DEPOSITIONS. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT DATE IS ESTIMATED. APPROXIMATE AGE OF DEVICE: 4 MONTHS. THE DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION IS NOT COMPLETE. NO FURTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT PRESENTED TO THE CLINIC WITH INCREASED WEAKNESS AND SHORTNESS OF BREATH AND HIGH PUMP POWERS. THERE WAS A SIGNIFICANT ELEVATION IN LACTATE DEHYDROGENASE (LDH) LEVELS AND OTHER LABORATORY VALUES SHOWED ACUTE RENAL FAILURE. THE PATIENT'S INR WAS 1.8 WITH A BASELINE OF 1.4 - 2.0 AND A TARGET OF 1.8-2.5. HISTORICALLY, COUMADIN DOSING WAS ADJUSTED ACCORDINGLY AND THE PATIENT WAS NOT FELT TO BE A CANDIDATE FOR LOVENOX BRIDGING DUE TO RECENT SURGICAL PROCEDURES. THE PATIENT WAS ADMITTED AND A HEPARIN INFUSION WAS INITIATED. THE PATIENT'S STATUS DETERIORATED RAPIDLY AFTER ADMISSION WITH WORSENING SHORTNESS OF BREATH, STEADILY INCREASING LDH LEVELS, AND DECREASED ESTIMATED PUMP FLOWS. THE PATIENT WAS MADE A DO NOT RESUSCITATE STATUS WITH COMFORT MEASURES PER THE FAMILY'S DECISION. THE PATIENT EXPIRED IN THE EVENING ON (B)(6) 2015. THE CAUSE OF DEATH WAS REPORTED BY THE VAD COORDINATOR AS INFECTION, SUSPECTED THROMBUS AND RENAL DYSFUNCTION. THE PATIENT HAD A PREVIOUSLY UNREPORTED PUMP POCKET INFECTION THAT WAS THOUGHT TO HAVE ORIGINATED FROM A (B)(6) INFECTION AT THE LEFT POST-IMPLANT CHEST TUBE SITE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND UNDERWENT DEBRIDEMENT OF THE PUMP POCKET INFECTION ON (B)(6) 2015 WITH PLACEMENT OF A WOUND VAC AT THE CHEST TUBE SITE FOR INFECTION MANAGEMENT. A LIMITED CARDIAC RELATED AUTOPSY WAS PERFORMED WITH EXPLANT OF THE LVAD. THE CONCLUSION STATED THAT THE PATIENT EXPIRED FROM COMPLICATIONS RELATED TO ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH ISCHEMIC CARDIOMYOPATHY. THE LVAD WAS RECOVERED, BUT WAS NOT EXAMINED AT THE TIME OF THE AUTOPSY. THE RESULTS NOTED A FEW MILLILITERS OF PURULENT EXUDATE SURROUNDING THE LVAD THAT CULTURED (B)(6) FOR (B)(6), VIRIDANS STREPTOCOCCUS GROUP, AND PREVOTELLA MELANINOGENICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608315 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death