BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 10304784 · Received July 21, 2020

    Report

    Report Number
    3007042319-2020-05023
    Event Type
    Death
    Date Received
    July 21, 2020
    Date of Event
    June 20, 2020
    Report Date
    April 26, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE LOG FILES WHICH REVEALED SEVERAL INCREASES AND DECREASES IN POWER CONSUMPTION STARTING (B)(6) 2020, INCLUDING SUDDEN, SHARP INCREASES IN POWER CONSUMPTION ON (B)(6) 2020 AND (B)(6) 2020 LEADING TO PARAMETERS ABOVE NORMAL OPERATING RANGE; 44 HIGH WATT ALARMS WERE LOGGED SINCE (B)(6) 2020. OF NOTE, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH MULTIPLE LYSIS THERAPY TREATMENTS, A HEPARIN INFUSION, AND CLOPIDOGREL MEDICATION, WHICH CORRESPONDS WITH THE DECREASES IN POWER CONSUMPTION OBSERVED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. PER THE VAD INSTRUCTIONS FOR USE, DEVICE THROMBUS IS A KNOWN POTENTIAL COMPL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF THROMBUS 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. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION AND UPDATE TO THE INVESTIGATION. CORRECTION B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS CORRECTED FROM LIFE THREATENING AND INTERVENTION REQUIRED TO DEATH. CORRECTION B5: EVENT DESCRIPTION WAS CORRECTED TO INCLUDE ADDITIONAL PATIENT SIGNS/SYMPTOMS AND PATIENT OUTCOME. CORRECTION H1: TYPE OF REPORTABLE EVENT WAS CORRECTED FROM SERIOUS INJURY TO DEATH. CORRECTION H6: PATIENT IME CODE AND IMF CODE WERE UPDATED. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00595825 DUE TO AN FDA AUDIT OBSERVATION. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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.

    Additional Manufacturer Narrative · 0

    ### A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR AN UPDATE TO THE INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: (B)(6) WAS NOT RETURNED FOR EVALUATION. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED SEVERAL INCREASES AND DECREASES IN POWER CONSUMPTION STARTING (B)(6) 2020, INCLUDING SUDDEN, SHARP INCREASES IN POWER CONSUMPTION ON 20/JUN/2020 AND 22/JUN/2020 LEADING TO PARAMETERS ABOVE NORMAL OPERATING RANGE; 44 HIGH WATT ALARMS WERE LOGGED SINCE (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED ANEMIA, ELEVATED LACTATE DEHYDROGENASE LEVELS, AND HYPERBILIRUBINEMIA. OF NOTE, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH MULTIPLE LYSIS THERAPY TREATMENTS, A HEPARIN INFUSION, AND CLOPIDOGREL MEDICATION, WHICH CORRESPONDS WITH THE DECREASES IN POWER CONSUMPTION OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS INTUBATED AND EXPERIENCED PULMONARY INFLAMMATION AND PNEUMONIC SHOCK. THE PATIENT SUBSEQUENTLY EXPIRED WITH CLINICAL SIGNS OF SEPSIS AND MULTIPLE ORGAN FAILURE (MOF). THE PATIENT'S OFFICIAL CAUSE OF DEATH WAS MOF. IT WAS REPORTED THAT THE SEPSIS CONTRIBUTED TO THE MOF, AND THE INFECTION AND MOF WERE NOT RELATED TO THE VAD. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. PER THE INSTRUCTIONS FOR USE, DEVICE T HROMBUS, INFECTION, MULTI-ORGAN FAILURE, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF SIMILAR ADVERSE 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. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) DUE TO AN FDA AUDIT OBSERVATION. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. ### MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA. IN ADDITION, THE PATIENT HAD ANEMIA, ELEVATED LACTATE DEHYDROGENASE LEVELS, HYPERBILIRUBINEMIA, AND A SUSPECTED VENTRICULAR ASSIST DEVICE (VAD) INFLOW CANNULA THROMBUS ASSOCIATED WITH PUMP HIGH POWER AND HIGH WATT ALARMS. IT WAS ALSO REPORTED THAT THE PATIENT'S ANTICOAGULATION MEDICATION WAS CONTROLLED AT THE TIME OF THIS EVENT. INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.3, PLASMA-FREE HEMOGLOBIN (HGB) WAS 30, C-REACTIVE PROTEIN (CRP) WAS 238, PROCALCITONIN (PCT) WAS 4.4, AND LEUKOCYTES WERE 11,000. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS DONE, AND THE PATIENT RECEIVED ANTIBIOTICS, HEPARIN INFUSION, CLOPIDOGREL MEDICATION AND FOUR LYSIS THERAPY TREATMENTS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS INTUBATED AND EXPERIENCED PULMONARY INFLAMMATION AND PNEUMOGENIC SHOCK. THE PATIENT SUBSEQUENTLY EXPIRED WITH CLINICAL SIGNS OF SEPSIS AND MULTIPLE ORGAN FAILURE (MOF). THE PATIENT'S OFFICIAL CAUSE OF DEATH WAS MOF. IT WAS REPORTED THAT THE SEPSIS CONTRIBUTED TO THE MOF, AND THE INFECTION AND MOF WERE NOT RELATED TO THE VAD.

    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 TRANS PLANTATION 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. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 EXPERIENCED ANEMIA, ELEVATED LACTATE DEHYDROGENASE LEVELS, HYPERBILIRUBINEMIA, AND A SUSPECTED VENTRICULAR ASSIST DEVICE (VAD) INFLOW CANNULA THROMBUS ASSOCIATED WITH THE VAD EXHIBITING HIGH POWER AND HIGH WATT ALARMS. IT WAS ALSO REPORTED THAT THE PATIENT'S ANTICOAGULATION MEDICATION WAS CONTROLLED AT THE TIME OF THIS EVENT. THE PATIENT RECEIVED A TRANSTHORACIC ECHOCARDIOGRAM, A HEPARIN INFUSION, CLOPIDOGREL MEDICATION AND FOUR LYSIS THERAPY TREATMENTS. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764999 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R| D