BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6979564 · Received October 26, 2017

    Report

    Report Number
    3007042319-2017-03831
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 7, 2017
    Report Date
    June 13, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTWARE® VENTRICULAR ASSIST SYSTEM PUMP MODEL: HW27592 PUMP / CATALOG NUMBER 1104 / EXPIRATION DATE 09/30/2018, CONCOMITANT MEDICAL PRODUCT: NO EVALUATED BY MFE: NO, DEVICE REMAINS IMPLANTED FDA METHOD CODE: 3317; 3372, FDA RESULTS CODE: 213. FDA CONCLUSION CODE: 22; 92. THE PUMPS WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT OF "LOW FLOWS/SUCTION" WITH THE LEFT VENTRICULAR ASSIST DEVICE (VAD) WERE CONFIRMED THROUGH LOG FILE ANALYSIS. THIS ANALYSIS REVEALED THIRTY-NINE LOW FLOW ALARMS LOGGED SINCE 25SEP2017 AND ONE SUCTION ALARM LOGGED ON 07OCT2017. THE REPORTED EVENT OF "INCREASE IN FLOW" WITH THE RIGHT VAD WAS CONFIRMED THROUGH LOG FILE ANALYSIS. THIS ANALYSIS REVEALED AN INCREASE IN POWER CONSUMPTION BEGINNING ON 06OCT2017. HOWEVER, NO ALARMS WERE LOGGED FOR FOURTEEN DAYS LEADING UP TO THE EVENT DATE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, THE POSSIBLE CAUSES OF LOW FLOW / SUCTION EVENTS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING, BUT NOT LIMITED TO, THROMBUS OR OTHER MATERIALS IN THE DEVICE, INFLOW CANNULA OBSTRUCTION, OR POOR VAD FILLING. BASED ON HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT MAY BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. 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. IN THIS CASE, THE PATIENT ALSO HAD A PRE-EXISTING RIGHT VENTRICULAR THROMBUS. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES FOR THIS COMPLAINTS: HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP, (B)(4) - PUMP / CATALOG NUMBER 1104 / EXPIRATION DATE 09/30/2018, DEVICE AVAILABLE FOR EVALUATION?: NO, NO, DEVICE REMAINS IMPLANTED, DEVICE MANUFACTURE DATE: 01/24/2016, LABELED FOR SINGLE USE?: YES, (B)(4). 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. 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

    A REPORT WAS RECEIVED THAT A PATIENT CALLED TO REPORT A PROLONGED SUCTION ALARM. THE PATIENT REPORTED THAT HE/SHE WAS MINIMALLY SYMPTOMATIC DURING THIS EVENT. A PRELIMINARY REVIEW OF THE LEFT VENTRICULAR (LV) VENTRICULAR ASSIST DEVICE (VAD) CONFIRMED LOW FLOW ALARMS AND A SUCTION ALARM. THE SITE INDICATED THAT THIS WAS PROBABLY DUE TO A HYPER-DYNAMIC LEFT VENTRICLE. THE PATIENT'S LVAD SPEED WAS ADJUSTED FROM 2200 RPM TO 2000 RPM. AN ECHOCARDIOGRAM REVEALED PERSISTENT AND PROGRESSIVE THROMBUS IN THE PATIENT RIGHT VENTRICULAR (RV) WITH VAD FLOWS OF 4.0 L/MIN. THE PATIENT HAD A PREVIOUS REPORT OF A THROMBUS INVOLVING HIS/HER RVAD IN (B)(6) 2017. THE PATIENT WAS ADMITTED ON (B)(6) 2017 FOR INSERTION OF A PERIPHERALLY-INSERTED CENTRAL CATHETER AND UNDERWENT THROMBOLYSIS ON (B)(6) 2017. THE PATIENT'S LVAD PARAMETERS ARE REPORTED TO HAVE REMAINED STABLE THROUGHOUT THE PROCEDURE; BUT RVAD ESTIMATED FLOWS INCREASED FROM 4.2 TO 8.9 L/MIN WITH A SPEED OF 1800 RPM. THESE FLOWS ARE REPORTED TO HAVE SETTLED AND TO HAVE THEN DECREASED TO 0.9 L/MIN. THE RVAD SPEED WAS THEN INCREASED TO 2000 RPM WITH THE SUBSEQUENT INCREASE OF ESTIMATED FLOWS TO 3.0 L/MIN. DURING THIS TIME, THE PATIENT COMPLAINED OF SOME SLIGHT CHEST PAIN. AN ECHOCARDIOGRAM REVEALED NO EVIDENCE OF TAMPONADE, PERICARDIAL BLEEDING OR BLEEDING. THE PATIENT WAS STARTED ON INTRAVENOUS HEPARIN AND WAS DISCHARGED TWO DAYS LATER. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758623 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R CONTROLLER - (B)(4)| CONTROLLER - (B)(4)| CONTROLLER - (B)(4)| CONTROLLER - (B)(4)