BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4931633 · Received July 22, 2015

    Report

    Report Number
    3007042319-2015-01540
    Event Type
    Death
    Date Received
    July 22, 2015
    Date of Event
    June 27, 2015
    Report Date
    July 8, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    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 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. HIGH WATTS ALARMS, AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP. THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL RECEIVED INFORMATION REPORTED THAT ON (B)(6) 2015, THE PARAMETERS OF THE PUMP "SHOWED VARIABILITY" AND "TWO REVISIONS" WERE MADE PRIOR TO PUMP REPLACEMENT. PUMP FLOW WAS CONTINUALLY RISING AND RPM WAS CONSTANTLY BEING INCREASED. PUMP PARAMETERS: 3020 RPM, FLOW 8.4, WATT 6.4; BUT THE "ECHO IS SEEN IN THE AMOUNT OF BLOOD IS NOT PUMPED" AND THERE IS NO LEAKAGE FROM THE AORTA. EXTRACORPOREAL MECHANICAL OXYGENATION (ECMO) WAS ATTACHED TO THE RIGHT SIDE OF THE HEART. THERE WAS BLEEDING AND "THEY MADE A REVISION". AFTER PUMP EXCHANGE, PUMP VALUES RETURNED TO NORMAL VALUES. HOWEVER, LATER THE BLEEDING BEGAN AND THEN THERE WAS A RISE IN THE VALUES OF THE PUMP, (REPORTED SEPARATELY). IT WAS REPORTED THAT THE CAUSE OF DEATH WAS HEMORRHAGE. INDEPENDENT PATHOLOGY REVIEW OF THE RETURNED PUMP REPORTED THAT GROSS FINDINGS ARE UNREMARKABLE; NO GROSS EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION WAS NOTED. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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, INCLUDING TRANSPORTATION. IMPLANTATION OF A VENTRICULAR ASSIST DEVICE (VAD) IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, A MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. BLEEDING IS A KNOWN POTENTIAL RISK THAT ALL PATIENTS IMPLANTED WITH VADS FACE AS OUTLINED IN THE INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

    THROMBUS AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL PROVIDE GUIDELINES ON PROPER USAGE OF THE HVAD SYSTEM AND PROGRAMMING HVAD PUMP PARAMETERS. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND ANTICOAGULATION RECOMMENDATIONS. LOG FILE ANALYSIS: A REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH THE EVENT CAPTURED, SHOWED AN INCREASING TREND IN ESTIMATED FLOW AND POWER CONSUMPTION STARTING ON (B)(6) 2015. PARAMETERS HAVE BEEN AT THE BORDERLINE OF NORMAL/ABOVE OPERATING RANGE. WAVEFORM TRENDS OF THIS NATURE MAY BE INDICATIVE OF A THROMBUS EVENT OR CHANGE IN PATIENT STATE. (B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED AN INCREASE IN POWER CONSUMPTION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION, DIMENSIONAL VERIFICATION AND FUNCTIONAL TESTING. INDEPENDENT PATHOLOGY REPORT DID NOT REVEAL EVIDENCE OF THROMBUS WITHIN THE PUMP. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AND PATIENT OUTCOME INCLUDE A COMPLICATED LVAD IMPLANT PROCEDURE DUE TO PUMP PARAMETER VARIABILITY REQUIRING TWO REVISIONS PRIOR TO PUMP REPLACEMENT AND ECMO SUPPORT; FOLLOWED BY UNCONTROLLED BLEEDING POST PUMP-EXCHANGE. INDEPENDENT PATHOLOGY REVIEW OF THE RETURNED PUMP REPORTED THAT GROSS FINDINGS ARE UNREMARKABLE; NO GROSS EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION WERE NOTED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT AND PATIENT OUTCOME WAS THE PATIENT'S COMPLICATED IMPLANT PROCEDURE AND POST-OPERATIVE PERIOD. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM (B)(6) THAT THE SITE REPORTED THAT PUMP THROMBOSIS WAS SUSPECTED BEGINNING (B)(6) 2015 DUE TO HIGH POWER CONSUMPTION. THE PATIENT HAD A PUMP EXCHANGE ON (B)(6) 2015 AND DIED ON (B)(6) 2015. NO FURTHER INFORMATION IS KNOWN AT THIS TIME WITH INVESTIGATION IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474954 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death