BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 10155376 · Received June 15, 2020

    Report

    Report Number
    3007042319-2020-03584
    Event Type
    Death
    Date Received
    June 15, 2020
    Date of Event
    May 4, 2020
    Report Date
    August 21, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED FROM THE SITE REVEALED THAT THE PATIENT EXPERIENCED ABDOMINAL BLEEDING AND NEUROLOGICAL DYSFUNCTION. THE PATIENT SHOWED SYNCOPE AND WAS TRANSFERRED TO A HEART TRANSPLANTATION CENTER. AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED HEMOPERITONEUM SPLENIC BLEEDING AND AN EMERGENCY SPLENECTOMY WAS PERFORMED. POST SURGERY, THE PATIENT SHOWED SIGNS OF SEIZURE, LOSS OF CONSCIOUSNESS AND RIGHT INTRACEREBRAL HEMORRHAGE (ICH) WITH MIDLINE SHIFT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE HVAD INSTRUCTIONS FOR USE, BLEEDING, NEUROLOGICAL DYSFUNCTION AND DEATH ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF AN HVAD PUMP. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF BLEEDING OR NEUROLOGICAL DYSFUNCTION 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. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 TRANS PLANTATION 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. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXPERIENCED AN ABDOMINAL BLEEDING AND A NEUROLOGICAL DYSFUNCTION. THE PATIENT FELL DOWN AND FRACTURED A FINGER AND WAS ADMITTED TO THE ORTHOPEDICS CLINIC. A PIN INSERTION SURGERY WAS PERFORMED. 1 DAY BEFORE THE SURGERY THE PATIENT BLOOD THINNER MEDICATION INTAKE WAS STOPPED AND WAS RESTORED AFTER THE FINGER SURGERY. DURING THE HOSPITALIZATION THE PATIENT SHOWED SYNCOPE AND WAS TRANSFERRED TO A HEART TRANSPLANTATION CENTER. THE PATIENT WAS ADMITTED WITH 6.0 HEMOGLOBIN (HB) AND AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED. THE DIAGNOSTIC TEST REVEALED HEMOPERITONEUM SPLENIC BLEEDING AND AN EMERGENCY SPLENECTOMY WAS PERFORMED. ON POST OF SURGERY (POD2) THE PATIENT RESTARTED HEPARINIZATION, SHOWED SEIZURE AND LOSS OF CONSCIOUSNESS. THE PATIENT SHOWED RIGHT INTRACEREBRAL HEMORRHAGE (ICH) WITH MIDLINE SHIFT, THIS WAS CONSULTED WITH THE NEUROSURGERY DEPARTMENT AND IT WAS DECIDED NOT TO FURTHER SURGICAL TREATMENT. THE FAMILY DECIDED NOT TO PROLONG LIFE TREATMENT AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618405 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death