BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5997835 · Received October 4, 2016

    Report

    Report Number
    3007042319-2016-03485
    Event Type
    Death
    Date Received
    October 4, 2016
    Date of Event
    January 12, 2016
    Report Date
    September 19, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED SECTIONS: AGE/DATE OF BIRTH, SEX, WEIGHT, DESCRIBE PROBLEM OR EVENT, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY, MFR CONTACT INFO, MANUFACTURER SITE, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, AND ADDITIONAL MFR NARRATIVE. ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS INITIALLY ADMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR DRIVELINE REVISION AND DEBRIDEMENT AND REMAIN HOSPITALIZED UNTIL THE PUMP EXCHANGE ON (B)(6) 2016. THE PATIENT REPORTEDLY HAD PERSISTENT DRAINAGE AND INFECTION IN THE DRIVELINE EXIT SITE FROM (B)(6) 2015 TO (B)(6) 2016, DESPITE MULTIPLE SURGICAL DEBRIDEMENTS AND SUPPRESSIVE INTRAVENOUS ANTIBIOTIC THERAPY. HOWEVER, THE PATIENT WAS STABLE OTHERWISE. IN THE OPERATION ROOM (OR) PRIOR TO THE PUMP EXCHANGE, FRIABLE TISSUE WAS ENCOUNTERED BEFORE THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. THE PATIENT WAS THOUGHT TO HAVE HAD AN AORTA RUPTURE AND BLED IN THE ABDOMEN. THE FAMILY DECLINED AN AUTOPSY AND THE DEVICE WOULD NOT BE RETURNED. THE OFFICIAL CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS PSEUDOMONAS LVAD INFECTION. THE MEDICAL TEAM DOES NOT BELIEVE THE DEATH WAS RELATED TO THE DEVICE. ADDITIONAL HISTORICAL INFO: PATIENT WAS SEEN IN LVAD CLINIC ON (B)(6) 2015 FOR EVALUATION OF ONE WEEK HISTORY OF PAIN AT DRIVELINE EXIT SITE AND ONE DAY HISTORY OF REDNESS AND DISCHARGE WHICH RETURNED AS PSEUDOMONAS ON (B)(6) 2015. PATIENT CONTINUED WITH SYMPTOMS WITH MULTIPLE CHANGES TO ANTIBIOTIC THERAPY FROM ORAL AND INTRAVENOUS THROUGHOUT THE MONTH OF (B)(6) 2015. ON (B)(6) 2015, PATIENT RETURNED FOR INCREASING DRAINAGE AND WAS ADMITTED FOR DEBRIDEMENT AND REMOVED OF DRIVELINE COVER. PATIENT WAS FOUND TO HAVE DEEP DRIVELINE INFECTION DOWN TO RECTUS MUSCLE AND A WOUND VAC WAS PLACED. ULTIMATELY, PSEUDOMONAS THEN FOUND TO BE RESISTANT TO CEFEPIME AND THE PATIENT WAS SWITCHED TO ZOSYN TO COMPLETE SIX-WEEK COURSE. ON (B)(6), THE PATIENT WAS RE-ADMITTED FOR SHORTNESS OF BREATH. HE STILL HAD YELLOW DRAINAGE FROM HIS DRIVELINE SITE AND IT WAS RECOMMENDED TO EXTEND ZOSYN BY ONE MORE WEEK AND THEN REASSESS. PATENT WAS SEEN AGAIN ON (B)(6) 2015 AND CONTINUED TO HAVE DRAINAGE, IMPROVING BUT DRESSING IS WET. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THOSE WITH COMPROMISED IMMUNE SYSTEMS AND/OR TREATED WITH MULTIPLE ANTIBIOTICS ARE MORE SUSCEPTIBLE TO THESE TYPES OF INFECTIONS. OTHER CONTRIBUTING FACTORS ALSO INCLUDE THE PATIENT'S BODY TYPE AND NUTRITIONAL STATUS, PLACEMENT, POSITION AND SIZE OF THE VAD, TENSION/ TRAUMA TO THE DRIVELINE EXIT SITE, AND DURATION OF TIME ON VAD SUPPORT. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. THE ROOT CAUSE OF THE DEATH CANNOT BE CONCLUSIVELY DETERMINED HOWEVER, PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. 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. DRIVELINE INFECTION IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL CONTAINS DRIVELINE INFECTION AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT AND COMMUNICATES POTENTIAL CAUSES AND SCENARIOS THAT COULD LEAD TO DRIVELINE INFECTION. MOREOVER, THE IFU FURTHER EDUCATES THE USER ON THE PRECAUTIONS AND WARNINGS TO REDUCE THE INCIDENCE AND SEVERITY OF INFECTION. DEATH AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS WITH PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IN OPERATING ROOM (OR) FOR POTENTIAL PUMP EXCHANGE RELATED TO EXTENSIVE DRIVELINE INFECTION. WHILE CANNULATING FOR FEMORAL BYPASS, VESSEL DAMAGE OCCURRED AND HEMOSTASIS COULD NOT BE ACHIEVED. AS A RESULT, THE PATIENT EXPIRED IN OPERATING ROOM (OR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647967 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death