BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 7771134 · Received August 9, 2018

    Report

    Report Number
    3007042319-2018-03638
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 25, 2018
    Report Date
    October 17, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY #(B)(4) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED A SLIGHT INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOW BEGINNING (B)(6) 2018. ONE (1) HIGH WATT ALARM WAS LOGGED ON (B)(6) 2018. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT PATIENT WAS ADMITTED TO THE HOSPITAL. PATIENT HAS HYPERTENSION AND DURING WEEKLY LABS IT WAS NOTED THAT PATIENT HAD BEEN THERAPEUTIC ON ANTICOAGULANTS. ON (B)(6) 2018 PATIENT HAD A SUDDEN HIGH WATT ALARM. ON (B)(6) 2018 PATIENT HAD NO ALARMS, FLOW AND POWER WERE STABLE. ON (B)(6) 2018 PATIENT HAD AMBER COLORED URINE. UPON ADMISSION, STARTED ON MEDICATION IMMEDIATELY, URINE REMAINED AMBER-CLEAR YELLOW, ECHO AND COMPUTED TOMOGRAPHY (CT) COMPLETED NEGATIVE. PIC PLACED, DEVELOPED (+) BLOOD CULTURE FOR KLEBSIELLA PNEUMONIA. SEPTIC APPEARING WITHIN 24 HOURS, TEMP 103 AND RIGORS, PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU). PATIENT WAS TRANSFUSED TWICE WITH TRANSFUSION REACTION TOWARDS THROMBOCYTOPENIA, COAGULANTS WERE VERY HIGH, REQUIRED PRODUCTS WITH PLATELETS AND FRESH FROZEN PLASMA (FFP). AFTER 24 HOURS ALL WAS CLEARED, DECISION WAS MADE FOR A PUMP EXCHANGE. ON (B)(6) 2018 LVAD WAS EXCHANGED. UPON INTRAOP INSPECTION, NO THROMBUS NOTED IN LEFT VENTRICLE (LV), INFLOW, OR OUTFLOW GRAFT. DEVICE IS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED WITH ELEVATED LACTATE DEHYDROGENASE (LDH) AND AMBER COLORED URINE. LABS ARE SUSPICIOUS FOR THROMBUS. DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612122 HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R