BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE

    MDR report key: 7668169 · Received July 6, 2018

    Report

    Report Number
    3007042319-2018-02893
    Event Type
    Injury
    Date Received
    July 6, 2018
    Date of Event
    August 22, 2017
    Report Date
    October 3, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    PRODUCT EVENT SUMMARY (B)(4) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT, NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO EVALUATE THE DEVICE CONFORMANCE TO INTERNAL RELEASE REQUIREMENTS AND/OR TO IDENTIFY ANOMALIES POTENTIALLY INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. REVIEW OF THE STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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, 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. 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

    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 ON (B)(6) 2017 PATIENT REPORTED SOME SEROUS DRAINAGE ON DRIVELINE DRESSING, DRIVELINE APPEARED STABLE AND NOT INFECTED. ON (B)(6) 2017 PATIENT REPORTED LESS ODOROUS DRAINAGE SINCE SHE BEGAN USING SILVER WITH HER DRESSING CHANGES HOWEVER STILL REPORTED OCCASIONAL DRAINAGE. PATIENT NOTED TO CONTINUE TO BE NON-COMPLIANT WITH ENDOCRINE MEDICATIONS. ON (B)(6) 2018 PATIENT CONTINUES DAILY DRESSINGS AND REPORTS OCCASIONAL DRAINAGE, BUT NO ODOR OR ERYTHEMA. PATIENT WAS SEEN ON (B)(6) 2018, REPORTING ODOR, DRAINAGE AND PAIN AT DRIVELINE EXIT SITE. CLINIC OBSERVED DRIVELINE SITE HAD A MODERATE AMOUNT OF PURULENT DRAINAGE, ODOROUS AND TENDER TO TOUCH. BLOOD CULTURES AND WOUND CULTURE WERE TAKEN WITH NO GROWTH. PATIENT WAS SEEN AGAIN (B)(6) 2018 AND STATED THAT FOR SEVERAL MONTHS, THERE HAS BEEN FOUL SMELLING MILKY/PINK DRAINAGE FROM EXIT WOUND AND SITE WAS TENDER. PATIENT UNDERWENT DRIVELINE DEBRIDEMENT ON (B)(6) 2018. ACCORDING TO PHYSICIAN THERE WAS OBVIOUS DRIVELINE INFECTION WITH PURULENT FOUL-SMELLING DISCHARGE COMING FROM THE DRIVELINE. THERE WAS HYPERTROPHIC GRANULATION TISSUE AND DRAINAGE PRESENT. THIS WAS AN EXCISIONAL DEBRIDEMENT OF SKIN AND SUBCUTANEOUS TISSUE. THE DRIVELINE TRACT AND DRIVELINE FLUID WERE SENT FOR CULTURE, TISSUE CULTURES WERE POSITIVE AND BLOOD CULTURE NEGATIVE. BOTH WERE THEN IRRIGATED WITH ANTIBIOTIC SOLUTION. A WET TO DRY DRESSING WAS PLACED AND PATIENT WAS TRANSFERRED TO CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU), PATIENT WAS ORDERED TO HAVE DRESSING CHANGED TWICE DAILY AND TO BEGIN WITH INTRAVENOUS ANTIBIOTIC DAILY AFTER DEBRIDEMENT AS WELL AS STARTING WITH CHRONIC PO SUPPRESSIVE THERAPY. DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510341 HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R