BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9593863 · Received January 15, 2020

    Report

    Report Number
    2916596-2020-00189
    Event Type
    Death
    Date Received
    January 15, 2020
    Date of Event
    December 23, 2019
    Report Date
    March 17, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: THE PATIENT WAS PREVIOUSLY ADMITTED FOR SUBARACHNOID HEMORRHAGIC STROKE (ADDRESSED IN MFR # 2916596-2019-06021). MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), IDENTIFIED A DEPOSITION IN THE EYE OF THE ROTOR; HOWEVER, THE REPORT OF SUSPECTED CLOT IN THE OUTFLOW GRAFT COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. IN ADDITION, A SPECIFIC CAUSE FOR THE REPORTED PATIENT OUTCOME DUE TO MULTISYSTEM ORGAN FAILURE SECONDARY TO SEPSIS, RESPIRATORY DISTRESS, AND SHOCKED LIVER COULD NOT BE CONCLUSIVELY DETERMINED. THE SUBMITTED CONTROLLER EVENT LOG FILE APPEARED TO CAPTURE THE PUMP FUNCTIONING AS INTENDED ABOVE THE LOW SPEED LIMIT WITH NO ATYPICAL ALARMS FROM (B)(6) 2019 AT 06:09:16 PM THROUGH (B)(6) 2019 AT 09:41:38 AM. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 2¿ FROM THE PUMP HEADER. THE MODULAR CABLE AND THE REMAINDER OF THE PUMP CABLE WERE NOT RETURNED. THE SEALED OUTFLOW GRAFT ATTACHMENT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE OUTFLOW GRAFT BEND RELIEF HARDWARE ENGAGED; HOWEVER, THE OUTFLOW GRAFT AND BEND RELIEF WERE SEVERED ADJACENT TO THE HARDWARE AND THE REMAINDER WAS NOT RETURNED. THE OUTFLOW GRAFT CLIP WAS RETURNED UNATTACHED FROM THE DEVICE. THE APICAL CUFF WAS RETURNED AND SECURED WITH THE FULLY ENGAGED CUFF LOCK. UPON DISASSEMBLY OF THE RETURNED DEVICE, A TISSUE-LIKE DEPOSITION WAS OBSERVED OCCLUDING THE EYE OF THE ROTOR. ALTHOUGH THE DEPOSITION WITHIN THE ROTOR WAS WELL-FORMED, IT WAS NOT STRONGLY ADHERED AND DID NOT REVEAL EVIDENCE OF LAMINATED LAYERING, SUGGESTING THAT IT LIKELY DID NOT FORM WITHIN THE PUMP AND WAS INGESTED INTO THE PUMP. THE EXACT ORIGIN OF THIS DEPOSITION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, IT COULD HAVE CONTRIBUTED TO A POTENTIAL FLOW ISSUE DUE TO OCCLUSION OF THE EYE OF THE ROTOR. THE ROTOR DEPOSITION WAS SENT OUT FOR HISTOPATHOLOGY ANALYSIS. PER THIS ANALYSIS, THE CLOTS FROM THE PUMP ROTOR CONSISTED PREDOMINANTLY OF DENSE FUNGAL MATS WITH SOME SURROUNDING FIBRIN AND FEW HOST CELLS. DUE TO THE LACK OF HOST CELLS, MOST OF WHICH WERE INTERPRETED AS MACROPHAGES, ACCURATE AGING OF THE CLOT IS DIFFICULT, BUT PROBABLY HAS BEEN PRESENT AT LEAST FIVE DAYS. DEPOSITIONS OF LOOSELY COAGULATED BLOOD WERE OBSERVED IN THE INFLOW CANNULA, OUTFLOW GRAFT ATTACHMENT, PUMP COVER, AND ROTOR WELL. THE LACK OF STRUCTURE OF THESE DEPOSITIONS SUGGESTS THAT THEY DEVELOPED ACUTELY, POTENTIALLY DUE TO POOR SURFACE WASHING AS A RESULT OF BLOOD REMAINING IN THE DEVICE POST-EXPLANT OR THE DECREASE IN FLOW OBSERVED IN THE RETRIEVED LVAD LOG FILES PRIOR TO THE DEVICE BEING TURNED OFF. EVALUATION OF THE LVAD LOG FILES RETRIEVED FROM MLP-011142 REVEALED THAT FLOW APPEARED TO STEADILY DECREASE ON (B)(6) 2019 STARTING AT 03:52:04 AM, UNTIL IT REACHED 0 LPM AT 04:07:03 AM. THESE EVENTS APPEAR CONSISTENT WITH THE REPORT THAT THE PATIENT EXPIRED ON (B)(6) 2019 AT 03:44 AM; HOWEVER, IT COULD ALSO BE CONSISTENT WITH OCCLUSION OF THE EYE OF THE ROTOR AS A RESULT OF THE OBSERVED DEPOSITION. DESPITE THE OBSERVED DECREASE IN FLOW, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED AT THE SET SPEED THROUGHOUT THE DURATION OF THE RETRIEVED DATA. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU LISTS PUMP THROMBOSIS, SEPSIS, RESPIRATORY FAILURE, AND HEPATIC DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO CLINIC ON (B)(6) 2019 FOR DRESSING CHANGE KITS, BUT STAFF OBSERVED THE PATIENT APPEARING SIGNIFICANTLY UNWELL AND IN RESPIRATORY DISTRESS. DURING ADMISSION HIS BRAIN BLEED, PATIENT HAD LEFT FROM THE ICU AGAINST ALL MEDICAL ADVICE. HIS INR IN THE ED IS 2.9, ELEVATED LACTATE, LACTATE DEHYDROGENASE (LDH) 3800 U/L, AND WORSENING CREATININE AND LIVER ENZYMES. BELIEVED TO HAVE SHOCK LIVER CONTRIBUTING TO THE ELEVATED INR IN THE ABSENCE OF ANTICOAGULATION. PATIENT STARTED ON LEVO, EPI, AND BIVAL IN THE ED. A CT SCAN REVEALED SUSPECTED CLOT AT THE VAD OUTLET NEAR THE AORTA. CT REPORT NOTED STENOSIS/THICKENING AT THE DESCENDING OUTFLOW GRAFT. PATIENT ALSO BELIEVED TO ALSO BE SUFFERING FROM A SUSPECTED ISCHEMIC BOWEL THAT THE PHYSICIANS BELIEVE TO BE RELATED TO THE CLOT FORMED IN THE OUTFLOW GRAFT. GENERAL SURGERY WAS CONSULTED FOR THE ISCHEMIC BOWEL. PATIENT PASSED AWAY ON (B)(6) 2019 OF MULTISYSTEM ORGAN FAILURE, SECONDARY TO SEPTIC SHOCK FROM UNKNOWN SOURCE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55097 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death| L| R