BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 7054370 · Received November 22, 2017

    Report

    Report Number
    3007042319-2017-04223
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    April 20, 2016
    Report Date
    January 17, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED 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 AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.' 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC ON (B)(6) 2016 FOR HIS/HER ROUTINE FOLLOW-UP VISIT. AT THAT TIME, THE PATIENT WAS AFEBRILE BUT WITH A SMALL AMOUNT OF THICK YELLOW SECRETIONS AT THE DRIVELINE (DL) EXIT SITE. THE SITE WAS CULTURED AND PROVED TO BE POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS STARTED ON ORAL LEVOFLOXACIN AND SENT HOME. HE/SHE MISSED A ¿COUPLE¿ OF SUBSEQUENT FOLLOW-UP VISITS AND THEN RETURNED TO THE CLINIC ON (B)(6) 2016. A CULTURE OF THE PATIENT¿S DL EXIT SITE REVEALED THAT IT WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS ADMITTED TO HOSPITAL AND STARTED ON INTRAVENOUS ZOSYN, NAFCILLIN, CETRIAXONE AND KEFZOL. WHILE HOSPITALIZED, THE PATIENT REPORTED THAT HE/SHE HAD BEEN WORKING ON A CAR AND DURING THIS TIME, A LARGE AMOUNT OF DRAINAGE WAS ¿PUSHED OUT¿. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED NO EVIDENCE OF A FLUID COLLECTION. HOWEVER, IT DID NOTE AN EMPYEMA THAT WAS DRAINED IN CLOSE PROXIMITY TO THE DL. THE PATIENT WAS LATER DISCHARGED HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE VAD DESTINATION THERAPY TRIAL CLINICAL STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC ON (B)(6) 2016 FOR HIS/HER ROUTINE FOLLOW-UP VISIT. AT THAT TIME, THE PATIENT WAS AFEBRILE BUT WITH A SMALL AMOUNT OF THICK YELLOW SECRETIONS AT THE DRIVELINE (DL) EXIT SITE. THE SITE WAS CULTURED AND PROVED TO BE (B)(6). THE PATIENT WAS STARTED ON ORAL LEVOFLOXACIN AND SENT HOME. HE/SHE MISSED A ¿COUPLE¿ OF SUBSEQUENT FOLLOW-UP VISITS AND THEN RETURNED TO THE CLINIC ON (B)(6) 2016. AT THAT TIME, THE PATIENT HAD DEVELOPED PNEUMONIA AND HAD (B)(6) BLOOD CULTURES THAT WERE UNRELATED TO THIS EVENT. A CULTURE OF THE PATIENT¿S DL EXIT SITE REVEALED THAT IT WAS (B)(6). THE PATIENT WAS ADMITTED TO HOSPITAL AND STARTED ON INTRAVENOUS ZOSYN, NAFCILLIN, CEFTRIAXONE AND KEFZOL. WHILE HOSPITALIZED, THE PATIENT REPORTED THAT HE/SHE HAD BEEN WORKING ON A CAR AND DURING THIS TIME, A LARGE AMOUNT OF DRAINAGE WAS ¿PUSHED OUT¿. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED NO EVIDENCE OF A FLUID COLLECTION. HOWEVER, IT DID NOTE AN EMPYEMA THAT WAS DRAINED IN CLOSE PROXIMITY TO THE DL. THE PATIENT WAS LATER DISCHARGED HOME. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833250 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R