BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9181157 · Received October 11, 2019

    Report

    Report Number
    2916596-2019-04633
    Event Type
    Death
    Date Received
    October 11, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 2, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS (RIGHT HEART FAILURE, RENAL DYSFUNCTION, BLEEDING, GASTROINTESTINAL BLEEDING, RESPIRATORY FAILURE, LOCALIZED INFECTION, SEPSIS, PATIENT CONDITION, AND PATIENT EXPIRATION) CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. C, CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS RIGHT HEART FAILURE, RENAL DYSFUNCTION, BLEEDING, RESPIRATORY FAILURE, LOCALIZED INFECTION, SEPSIS, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 LISTS INFECTION AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO RANGE IS ALSO INCLUDED IN THIS SECTION. ADDITIONALLY, SECTION 6 STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP.¿ CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THIS DOCUMENT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 07JAN2019. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE PATIENT¿S EXPIRATION AND (B)(4) CANNOT BE CONCLUSIVELY DETERMINED. THE PATIENT EXPIRED ON (B)(6) 2019 DUE TO UNKNOWNS CAUSES. NO ALARMS, CLINICAL SYMPTOMS, OR DEVICE-RELATED ISSUES WERE REPORTED IN ASSOCIATION WITH THE EVENT. IT WAS REPORTED THAT AN AUTOPSY WOULD NOT BE PERFORMED AND HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), WOULD NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE LISTS DEATH AS AN ADVERSE EVENT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2019 WITH RIGHT VENTRICULAR FAILURE (RVF) AND VOLUME OVERLOAD. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6) 2019 FOR HEART-KIDNEY TRANSPLANT WORKUP. PATIENT WAS PLACED ON RIGHT VENTRICULAR ASSIST DEVICE(RVAD) ON (B)(6) 2019 FOR RVF. PATIENT UNDERWENT CONTINUOUS RENAL REPLACEMENT THERAPY ON (B)(6) 2019 TO ADDRESS ACUTE KIDNEY INJURY/CHRONIC KIDNEY DISEASE(AKI/CKD). PATIENT'S EPISTAXIS WAS REGULATED VIA NASAL PACKING. PATIENT SEEN TO HAVE NECROTIC ESOPHAGUS ON AN ESOPHAGOGASTRODUODENOSCOPY(EGD), (B)(6) 2019, PRECLUDING ENTERAL FEEDING TUBE PLACEMENT. PATIENT WAS HEALING FROM NECROTIC ESOPHAGUS ON (B)(6) 2019, WHICH ALLOWED DUOTUBE TO BE PLACED AND TUBE FEEDS HAD RESUMED. PATIENT HAD SYMPTOMS OF HEMATOCHEZIA/MELENA, THIS WAS ADDRESSED WITH ~1 UNIT OF RED BLOOD CELLS PER DAY. PATIENT WAS REINTUBATED ON (B)(6) 2019 FOR RESPIRATORY FAILURE AND HYPERCARBIA. PATIENT UNDERWENT COLONOSCOPY ON (B)(6) 2019 WITH BLOOD FOUND IN COLON, HOWEVER, SITE WAS UNABLE TO LOCALIZE THE BLEEDING. PATIENT WAS NOT A CANDIDATE FOR INTERVENTIONAL RADIOLOGY, PATIENT WAS TOO SICK FOR TAGGED RED BLOOD CELL SCAN. IT WAS DETERMINED PATIENT REQUIRES 1-3 UNITS OF RED BLOOD CELLS PER DAY AND VOLUME PRESSORS. PATIENT UNDERWENT DAILY SPONTANEOUS BREATHING TRIALS(SBT), HOWEVER PATIENT WAS EXTREMELY WEAK AND UNLIKELY TO BE EXTUBATED. PATIENT'S RECENT SEPSIS LIKELY FROM PNEUMONIA WITH RESPONDS TO STEROIDS. PATIENT WAS NOT A TRANSPLANT CANDIDATE. ON (B)(6) 2019 PATIENTS GASTROINTESTINAL BLEEDING SEEMED TO BE IMPROVING. PATIENT WAS EXTUBATED ON (B)(6) 2019, AND BEGAN EXPRESSING WISHES TO DIE AND NOT CONTINUE WITH MEDICAL CARE. PATIENT EXPERIENCED A NEW SEPTIC EPISODE OR ANOTHER BLEEDING EPISODE ON (B)(6) 2019 . PATIENT WAS MADE DO NOT RESUSCITATE(DNR) WITH NO ESCALATION OF CARE. PATIENT PASSED AWAY ON (B)(6) 2019 DUE TO MULTISYSTEM ORGAN FAILURE.

    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 IN THE PATIENT OUTCOME THAT THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. NO FURTHER INFORMATION WAS PROVIDED. NO AUTOPSY WILL BE PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974750 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6783723 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death