BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP

    MDR report key: 6445986 · Received March 30, 2017

    Report

    Report Number
    3007042319-2017-00912
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    October 3, 2016
    Report Date
    January 19, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS HAVE BEEN UPDATED ACCORDINGLY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT'S DRIVELINE (DL) EXIT SITE WAS POSITIVE FOR KLEBSIELLA OXYTOCA. THE PATIENT WAS TREATED WITH THE SURGICAL DEBRIDEMENT OF THE SITE ON (B)(6) 2016. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016 ON MINOCYCLINE FOR CONTINUED SUPPRESSIVE THERAPY. NO FURTHER INFORMATION HAS BEEN PROVIDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. THE 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. IT IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE SYSTEM IS INDICATED FOR USE UNDER THE DIRECT SUPERVISION OF A LICENSED PRACTITIONER OR BY PERSONNEL TRAINED IN ITS' PROPER USE. THESE PROFESSIONALS SHOULD BE AWARE OF THE PHYSICAL AND PSYCHOLOGICAL NEEDS OF PATIENTS UNDERGOING LVAD SUPPORT. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL PROVIDE GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF INFECTION, INCLUDING NON-DEVICE RELATED INFECTIONS. INFECTION AND SEPSIS ARE KNOWN POTENTIAL COMPLICATIONS OF PATIENTS AFTER ANY SURGICAL PROCEDURES OR IN THOSE WITH OPEN ACCESS SITES. THE PUMP REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. THERE IS ALSO NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME CAN BE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE AND THE PATIENT'S RELATED COMORBIDITIES. IN THIS CASE THESE FACTORS MAY HAVE INCLUDED THE PROGRESSIVE NATURE OF THE PATIENT'S UNDERLYING DISEASE PROCESS AND HIS HISTORY OF A PREVIOUS DRIVELINE INFECTION. THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS TREATED WITH SURGICAL DEBRIDEMENT OF THE DRIVELINE (DL) ON (B)(6) 2016. THE PATIENT WAS SUBSEQUENTLY TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 ON CONTINUED SUPPRESSIVE INTRAVENOUS ANTIBIOTICS. THE PERIPHERALLY-INSERTED CENTRAL CATHETER (PICC) LINE WAS REMOVED ON (B)(6) 2016 AT AN OFFICE VISIT. DURING THAT VISIT, THE DL WAS NOTED TO HAVE CONTINUED SEROSANGUINOUS DRAINAGE WITH 2+ STENOTROPHOMONAS. THE PATIENT¿S ANTIBIOTICS WERE ADJUSTED. ON (B)(6) 2017, THE PATIENT¿S DL WAS NOTED TO HAVE ONGOING DRAINAGE. A CULTURE OF THE DL EXIT SITE REVEALED KLEBSIELLA OXYTOCA WITH FURTHER ANTIBIOTICS ADJUSTMENTS. THE PATIENT WAS SEEN IN (B)(6) 2017 WITH ONGOING DL EXIT SITE INFECTION. CULTURES AT THAT TIME PROVED TO BE POSITIVE FOR PSEUDOMONAS PUTIDA, KLEBSIELLA OXYTOCA AND STENOTROPHOMONAS. THE PATIENT WAS RE-ADMITTED TO HOSPITAL ON (B)(6) 2017 WITH ERYTHEMA AND DRAINAGE FROM THE DL EXIT SITE. THE PATIENT UNDERWENT CARDIAC TRANSPLANTATION ON (B)(6) 2017. THE PATIENT IS A PARTICIPANT IN THE VAD DESTINATION THERAPY TRIAL IMPROVED BLOOD PRESSURE MANAGEMENT CLINICAL STUDY.

    Description of Event or Problem · 1

    UPDATED NARRATIVE:ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT¿S PERIPHERALLY-INSERTED CENTRAL CATHETER WAS REMOVED DURING AN OFFICE VISIT ON (B)(6) 2016. THE EVENT WAS REPORTED TO HAVE BEEN RESOLVED ON (B)(6) 2016. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE CLINICAL DATABASE THAT A PATIENT WAS ADMITTED TO HOSPITAL WITH A DRIVELINE (DL) INFECTION ON (B)(6) 2016. DETAILS REGARDING THE PATIENT'S SYMPTOMS AND THE RESULTS OF ANY DIAGNOSTIC TESTING WERE NOT PROVIDED. HE WAS TREATED WITH SURGICAL INTERVENTION. THE EVENT WAS REPORTED TO HAVE BEEN RESOLVED ON (B)(6) 2016. THE PRIMARY INVESTIGATOR REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE PATIENT'S CONDITION AND HVAD SYSTEM AND UNRELATED TO THE HVAD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228505 HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R