BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 10036506 · Received May 7, 2020

    Report

    Report Number
    3007042319-2020-03109
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    April 24, 2020
    Report Date
    January 7, 2021
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT A CONTROLLER FAULT ALARM INDICATIVE OF AN INTERNAL BATTERY FAULT WAS TRIGGERED 30 MINUTES AFTER POWERING UP THE CONTROLLER AND THE NO POWER ALARM SOUNDED FOR ONLY TWO (2) SECONDS WHEN BOTH POWER SOURCES WERE DISCONNECTED FROM THE CONTROLLER DURING BENCH TESTING. AN INTERNAL INSPECTION OF THE CONTROLLER REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY THAT POWERS THE NO POWER ALARM WAS SWOLLEN AND THE VOLTAGE OF THE CELLS WAS BELOW THE EXPECTED VALUE. AFTER THE BATTERY WAS REPLACED, THE CONTROLLER PERFORMED AS INTENDED. LOG FILE ANALYSIS REVEALED A CONTROLLER FAULT ALARM LOGGED ON (B)(6) 2020 AT 15:47:05, INDICATING AN INTERNAL BATTERY FAULT. AS A RESULT, THE REPORTED CONTROLLER FAULT ALARM EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONTROL LER FAULT ALARM EVENT CAN BE ATTRIBUTED TO A FAULTY INTERNAL NIMH BATTERY. 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 R ELATED 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. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 131 H6: FDA CONCLUSION CODE(S): 4307 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

    AS A RESULT OF REVIEW OF THE COMPLAINT FILE, THIS REPORT CONTAINS UPDATES TO THE EVALUATION RESULT AND CONCLUSION CODES AND THE PRODUCT EVENT SUMMARY TO MORE ACCURATELY REFLECT WHAT IS IN THE COMPLAINT FILE. THE PREVIOUSLY REPORTED FAILURE FINDINGS REMAIN UNCHANGED. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6), H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. THE HVAD PUMP (B)(6) WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT A CONTROLLER FAULT ALARM INDICATIVE OF AN INTERNAL BATTERY FAULT WAS TRIGGERED 30 MINUTES AFTER POWERING UP THE CONTROLLER AND THE NO POWER ALARM SOUNDED FOR ONLY TWO (2) SECONDS WHEN BOTH POWER SOURCES WERE DISCONNECTED FROM THE CONTROLLER DURING BENCH TESTING. AN INTERNAL INSPECTION OF THE CONTROLLER REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY THAT POWERS THE NO POWER ALARM WAS SWOLLEN AND THE VOLTAGE OF THE CELLS WAS BELOW THE EXPECTED VALUE. AFTER THE BATTERY WAS REPLACED, THE CONTROLLER PERFORMED AS INTENDED. LOG FILE ANALYSIS REVEALED A CONTROLLER FAULT ALARM LOGGED ON (B)(6) 2020 AT 15:47:05, INDICATING AN INTERNAL BATTERY FAULT. ADDITIONALLY, LOG FILES REVEALED THAT THE CONTROLLER WAS IN USE FOR MORE THAN TWO (2) YEARS. AS A RESULT, THE REPORTED CONTROLLER FAULT ALARM EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONTROLLER FAULT ALARM EVENT CAN BE ATTRIBUTED TO A FAULTY INTERNAL NIMH BATTERY. AN INTERNAL INVESTIGATION WAS INITIATED TO EVALUATE THIS ISSUE. 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.

    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. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER 2.0. MODEL #: 1420, CATALOG #: 1420, EXPIRATION DATE: 30-JUN-2018, SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 07-MAY-2020 DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES. DEVICE MANUFACTURE DATE: MFG DATE: 16-JUN-2017. LABELED FOR SINGLE USE: NO. (B)(4). 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 CONTROLLER ALARMED WITH A CONTROLLER FAULT ALARM AND DID NOT RESOLVE. THE CONTROLLER WAS EXCHANGED WITH NO ISSUES AT THE PATIENT¿S HOME VIA VERBAL SUPPORT WITH THE HOSPITAL. THIRTY MINUTES LATER, IT WAS NOTED THAT THE PATIENT HAD LOST VISION AND FELT SLIGHTLY DIZZY. THE PATIENT WAS ADVISED TO GO THE EMERGENCY ROOM AND WAS ADMITTED WITH NEW LEFT PARIETAL AND TEMPORAL INFARCT. THE PATIENT CONTINUED TO HAVE VISION LOSS, SLURRED SPEECH, EXPRESSIVE AND RECEPTIVE APHASIA. THE PATIENT REMAINED ADMITTED WITH SUSPECTED CEREBROVASCULAR ACCIDENT (CVA) SYMPTOMS INCLUDING BUT NOT LIMITED TO SLURRED SPEECH, BLINDNESS, AND SPEECH CHANGES. THE VENTRICULAR ASSIST DEVICE (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
    498632 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization