BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 7304703 · Received February 28, 2018

    Report

    Report Number
    3007042319-2018-00875
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 5, 2018
    Report Date
    August 15, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. HAS BEEN UPDATED TO REFLECT THIS REPORT. F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: 2100020000-2018-8007 F3 USER FACILITY NAME/ADDRESS UNIVERSITY OF MARYLAND MEDICAL CENTER 22 SOUTH GREENE ST. BALTIMORE, MD 21201 F4 CONTACT PERSON: ASHLEY MIKHAIL F5 PHONE NUMBER: 667-214-1251 DATE USER FACILITY BECAME AWARE OF EVENT: UNKNOWN F7 TYPE OF REPORT: INITIAL F8 DATE OF THIS REPORT: XX-JUL-2018 F9 APPROXIMATE AGE OF DEVICE: 0 F10 EVENT PROBLEM CODES: N/A F11 REPORT SENT TO FDA: N/A F12 LOCATION WHERE EVENT OCCURRED: N/A F13 REPORT SENT TO MANUFACTURER: YES, XX-JUL-2018 F14 MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC ADDL: 8200 CORAL SEA STREET NE CITY: MOUNDS VIEW STATE: MN ZIP: 55112 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THE ISCHEMIC STROKE LEAD TO DENSE HEMIPLEGIA AND THE PATIENT¿S INABILITY TO MANAGE THEIR VENTRICULAR ASSIST DEVICE (VAD) INDEPENDENTLY.

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICE MET ALL THE REQUIREMENTS FOR RELEASE. THE REPORTED "HIGH POWER" EVENT WAS CONFIRMED DURING THE ANALYSIS OF LOG FILES WHICH REVEALED AN INCREASE IN THE PUMP'S POWER CONSUMPTION BEGINNING ON (B)(6) 2018. THIRTY-FOUR HIGH WATT ALARMS WERE LOGGED FROM (B)(6) 2018 TO (B)(6) 2018. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED "HIGH POWER" EVENT CAN BE ATTRIBUTED TO THE 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. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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 TO THE HOSPITAL WHEN THEY DEVELOPED SHORTNESS OF BREATH, DARK ¿COKE¿ COLORED URINE, AND SIGNS OF HEMOLYSIS WHEN THEIR VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED AN ACUTE POWER RISE DUE TO A POSSIBLE PUMP THROMBUS. IT WAS NOTED THAT THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) AND PLASMA FREE HEMOGLOBIN (HGB) WERE ELEVATED. THE PATIENT UNDERWENT A PUMP EXCHANGE AND A SMALL THROMBUS WAS FOUND INSIDE THE PUMP. DURING THE EXCHANGE, THE PATIENT EXPERIENCED A MASSIVE EMBOLIC STROKE. THE PATIENT REMAINS HOSPITALIZED IN CRITICAL CONDITION ON A VENTILATOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147597 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R DVBB1D4 ICD, 6947M62 LEAD