BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 6760787 · Received August 2, 2017

    Report

    Report Number
    3007042319-2017-02462
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    March 22, 2019
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: INITIAL REPORTER NAME AND ADDRESS. PRODUCT EVENT SUMMARY: THE HVAD PUMP AND OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING AND STERILITY DOCUMENTATION ASSOCIATED WITH THE VENTRICULAR ASSIST DEVICE (VAD) CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE OUTFLOW GRAFT'S STERILITY DOCUMENTATION COULD NOT BE CONDUCTED, AS THE LOT NUMBER WAS UNKNOWN. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED AN INCREASE IN POWER CONSUMPTION STARTING (B)(6) 2017 AND 11 HIGH WATT ALARMS LOGGED SINCE (B)(6) 2017. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. 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. OTHER DEVICES INVOLVED IN THIS EVENT: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM : OUTFLOW GRAFT, OUTFLOW GRAFT/ UNK/ MODEL #: 1125/ CATALOG #: 1125, ASKU CONCOMITANT MEDICAL PRODUCTS: NO, DEVICE EVALUATED BY MFR: DEV RTN TO MFR? NO, LABELED FOR SINGLE USE: YES. PATIENT CODE(S): C34582, C26686, C26791, C27083, C2890, DEVICE CODE(S): C62897, FDA METHOD CODE(S): 4112, 4114, FDA RESULTS CODE(S): 213, FDA CONCLUSION CODE(S): 22, 67 THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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. 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 THAT THE PATIENT DEVELOPED AN ABSCESS WITH SPLINTER HEMORRHAGES IN THEIR FINGERS AND TOES. IT WAS NOTED THAT THE EVENT WAS ASSOCIATED WITH HIGH WATT ALARMS.

    Additional Manufacturer Narrative · 1

    (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED AN INCREASE IN POWER CONSUMPTION STARTING (B)(6) 2017 AND 11 HIGH WATT ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2017. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. BASED ON THE HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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. 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

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED AND ENDOCARDITIS WAS DETECTED ON THE OUTFLOW GRAFT BY POSITRON EMISSION TOMOGRAPHY (PET) SCAN. POWER CONSUMPTION SHOWED A SLIGHT INCREASE AND LEAD TO SUSPICION OF PUMP THROMBUS. THE PATIENT WAS TRANSPORTED TO A DIFFERENT HOSPITAL AND WAS PUT ON THE HIGH URGENCY (HU) WAITING LIST FOR TRANSPLANTATION. PATIENT GOT TRANSPLANTED ON (B)(6) 2017 AND IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542482 HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R