BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8207345 · Received January 1, 2019

    Report

    Report Number
    3007042319-2019-07390
    Event Type
    Death
    Date Received
    January 1, 2019
    Date of Event
    December 4, 2018
    Report Date
    April 30, 2019
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (HW34200) WITH A SEGMENT OF THE ASSOCIATED OUTFLOW GRAFT (LOT #17103319-0690) AND VAD PUMP (HW32254) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH HW34200 REVEALED A DECREASE IN POWER CONSUMPTION ON (B)(6) 2018 TO PARAMETERS BELOW THE NORMAL OPERATING RANGE AND WAS FOLLOWED BY A RETURN TO NORMAL OPERATING RANGE ON 06-DEC-2018. A SUBSEQUENT DECREASE IN POWER CONSUMPTION WAS OBSERVED ON (B)(6) 2018 LEADING TO PARAMETERS BELOW THE NORMAL OPERATING RANGE. THERE WERE 127 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2018. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH HW32254 REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION BEGINNING (B)(6) 2018 AND WAS FOLLOWED BY A RETURN TO BASELINE PARAMETERS ON (B)(6) 2018. A SUBSEQUENT DECREASE IN POWER CONSUMPTION WAS OBSERVED ON (B)(6) 2018. TWO LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2018. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. FAILURE ANALYSIS OF THE RETURNED PUMPS REVEALED THAT THE D EVICES PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING, AND DIMENSIONAL VERIFICATION. INTERNAL PATHOLOGICAL REPORT OF THE PUMPS REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICES. FAILURE ANALYSIS OF THE RETURNED SEGMENT OF OUTFLOW GRAFT REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION. INTERNAL PATHOLOGICAL REPORT REVEALED EVIDENCE OF THROMBUS WITHIN THE OUTFLOW GRAFT. THERE IS NO EVIDENCE OF A MALFUNCTION THAT MAY HAVE PREVENTED THE DEVICES FROM PERFORMING AS INTENDED. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED. 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. OTHER DEVICES INVOLVED IN THIS EVENT: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP PUMP/ HW32254 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP. PUMP/ (B)(4)/ MODEL #: 1104/ CATALOG #: 1104/ EXPIRATION DATE: 2020-03-31. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2018-03-22. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT. OUTFLOW GRAFT/ (B)(4)/ MODEL #: 1125/ CATALOG #: 1125/ EXPIRATION DATE: 2022-11-30. UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-11-01. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR LOW FLOWS, DECREASE IN POWER CONSUMPTION AND APPEARED DEHYDRATED. IT WAS NOTED THAT THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC UPON ADMISSION AND THE PATIENT CONTINUED TO DECOMPENSATE DUE TO RIGHT VENTRICULAR ASSIST DEVICE (VAD) OCCLUSION OF THE OUTFLOW GRAFT. THE PATIENT DEVELOPED ACUTE EXACERBATION OF HEART FAILURE AS A RESULT OF INADEQUATE FLOW RATE DUE TO THE RIGHT VAD OCCLUSION PREVENTING BLOOD FLOW FORWARD TO THE LEFT VAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HEMOLYSIS, LABORATORY IMAGING REVEALED LEFT VENTRICULAR (LV) THROMBUS, AND THE PATIENT WAS STARTED ON INTRAVENOUS (IV) ANTICOAGULANTS. THE PATIENT ACQUIRED MULTI SYSTEM ORGAN FAILURE (MSOF), ACUTE KIDNEY FAILURE, AND SEVERE ACIDOSIS. THE PATIENT WAS NOT CONSIDERED A SURGICAL CANDIDATE FOR A PUMP EXCHANGE DUE TO SEVERE MSOF AND PALLIATIVE CARE WAS PLACED ON CONSULT ON (B)(6) 2018. THE PATIENT¿S FAMILY ELECTED TO WITHDRAW CARE ON (B)(6) 2018 AND THE PATIENT SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH WAS DUE TO PUMP THROMBOSIS AND CARDIOGENIC SHOCK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death