BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 3662981 · Received March 6, 2014

    Report

    Report Number
    3007042319-2014-00167
    Event Type
    Death
    Date Received
    March 6, 2014
    Date of Event
    January 20, 2014
    Report Date
    May 18, 2022
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE DEVICE IS NOT GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS (3007042319-2014-167 AND 3007042319-2014-169) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. SITE INDICATED IT WOULD NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES REVEALED A DECREASE IN POWER CONSUMPTION AND FLOW, AS WELL AS "LOW FLOW" ALARMS FOR BOTH RVAD AND LVAD THAT CORRELATE WITH THE REPORTED EVENT. ADDITIONALLY, BOTH CONTROLLERS, (B)(4) WERE RETURNED AND EVALUATED. THE CONTROLLERS PASSED FUNCTIONAL EXAMINATION; HOWEVER IT WAS INCIDENTALLY FOUND THAT ONE OF THE CONTROLLERS HAD A DAMAGED SERIAL PORT CONNECTOR. THE DAMAGED SERIAL PORT CONNECTOR WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENTS. INVESTIGATIONS OF COMPLAINTS WITH SIMILAR CIRCUMSTANCES WERE REVIEWED; A DECREASE IN FLOW MAY BE DUE TO PUMP THROMBUS/THROMBOSIS, INADEQUATE PRELOAD, PATIENT'S CLINICAL STATE, OR VENTRICULAR COLLAPSE. WHILE THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; BASED ON THE SURGEON'S OPINION THE MOST LIKELY CAUSE OF THE LOW FLOW EVENTS IS THE PATIENT'S REPORTED HYPOTENSION. THE REPORTED CAUSE OF DEATH WAS CARDIAC ARREST. 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. PER THE INSTRUCTIONS FOR USE (IFU):ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE DEVICE THROMBOSIS AND WORSENING HEART FAILURE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2014-167 AND 3007042319-2014-169) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. HVAD PUMP ((B)(4)) AND CONTROLLERS, ((B)(4)) WERE RETURNED TO HEARTWARE FOR EVALUATION. HVAD PUMP ((B)(4)) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE CONTROLLERS PASSED FUNCTIONAL EXAMINATION; HOWEVER IT WAS INCIDENTALLY FOUND THAT ONE OF THE CONTROLLERS HAD A DAMAGED SERIAL PORT CONNECTOR. THE DAMAGED SERIAL PORT CONNECTOR WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENTS. POST-EXPLANT DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED PUMP DID NOT INDICATE ANY DEVIATIONS FROM CURRENT MANUFACTURING AND FUNCTIONAL SPECIFICATIONS; THERE IS NO EVIDENCE OF ANY CONDITIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE CONTROLLER LOG FILES REVEALED A SUDDEN DROP IN FLOW IN BOTH LVAD AND RVAD PUMPS, AS WELL AS "LOW FLOW' ALARMS THAT CORRELATE WITH THE REPORTED EVENT. A SUDDEN DECREASE IN FLOW OBSERVED ON THE LOG FILES SUGGESTS AN OCCLUSION OF THE FLOW PATH. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. INDEPENDENT PATHOLOGICAL ANALYSIS DID NOT REVEAL THROMBUS WITHIN (B)(4) (RVAD); HOWEVER, (B)(4) (LVAD) WAS NOT RETURNED FOR EVALUATION AND PATHOLOGICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE OF THE REPORTED INADEQUATE FLOW EVENTS MAY BE DUE TO INFLOW OCCLUSION. 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. PER THE INSTRUCTIONS FOR USE (IFU):ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE DEVICE THROMBOSIS AND WORSENING HEART FAILURE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2014-00167 AND 3007042319-2014-00169) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. TWO BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. ANALYSIS OF THE DEVICES REVEALED THAT BATTERY ((B)(4)) MET SPECIFICATIONS; THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY ((B)(4)) FAILED TO MEET SPECIFICATIONS; THE BATTERY WAS OUT OF CALIBRATION. THIS WAS AN INCIDENTAL FINDING AND NOT RELATED TO THE REPORTED EVENT. LOG FILES WERE NOT AVAILABLE AND THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH PREMATURE POWER SWITCHING OF SCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE IS A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. ON (B)(6) 2014, A FIELD SAFETY NOTICE ((B)(4)) WAS ISSUED TO US PHYSICIANS TOGETHER WITH A PATIENT LETTER TO BE DELIVERED BY SITES TO PATIENTS CURRENTLY ON DEVICE. THE FIELD SAFETY NOTICE AND PATIENT LETTER WERE INTENDED TO ENABLE PATIENTS TO RECOGNIZE ABNORMALLY BEHAVING BATTERIES AND TO SPECIFY ACTIONS TO TAKE WHEN A BATTERY NEEDS TO BE REPLACED. THE COMMUNICATIONS OUTLINED GENERAL POWER MANAGEMENT REQUIREMENTS AND FOCUSED ON RECOGNIZING THE ALARMS AND MESSAGE DISPLAYS RELATED TO THE SPECIFIC FAILURE MODES. BOXED INSTRUCTIONS WERE PROVIDED IN THE FIELD SAFETY NOTICE TO PROVIDE ADVICE TO PATIENTS AND SITES ON HOW TO RESPOND IN THE EVENT OF PREMATURE BATTERY SWITCHING, RAPID CAPACITY CHANGE, OR RAPID SWITCHING BACK AND FORTH. ADDITIONALLY, (B)(4) WAS ISSUED AS A VOLUNTARY "URGENT MEDICAL DEVICE CORRECTION"; COMMUNICATION WAS ISSUED TO THE SITES AND PATIENTS WITHIN THE UNITED STATES ON (B)(6) 2015. AN "URGENT FIELD SAFETY NOTICE" WAS SENT TO SITES AND PATIENTS NOT WITHIN THE UNITED STATES ON (B)(6) 2015. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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

    APPROXIMATELY THREE AND A HALF MONTHS POST BIVAD IMPLANTATION THIS PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED. THE PATIENT HAD BEEN HOSPITALIZED AT THE TIME OF THE EVENT AND REVIEW OF THE PATIENT LOG FILES REVEALED LOW FLOW ALARMS IN BOTH THE RVAD AND LVAD. TPA WAS ADMINISTERED BUT LOW FLOW PERSISTED AND THE PATIENT EXPIRED SEVERAL HOURS LATER. CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. AN AUTOPSY WAS PERFORMED AND THE PUMPS WERE EXPLANTED. DETAILS REGARDING THE AUTOPSY FINDINGS HAVE NOT PROVIDED. THE SITE STATED THAT ONLY THE RVAD WOULD BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135685 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death (B)(6) VAD.| (B)(6)- CONTROLLER.| (B)(6)- CONTROLLER.| (B)(6)- PUMP.| (B)(4) - CONTROLLER| (B)(4) - CONTROLLER