BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 12666425 · Received October 20, 2021

    Report

    Report Number
    3007042319-2021-07722
    Event Type
    Death
    Date Received
    October 20, 2021
    Date of Event
    May 20, 2020
    Report Date
    November 4, 2021
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION AND INVESTIGATION COMPLETION. THIS SUPPLEMENTAL INCLUDES THE RECEIPT OF A MAUDE REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT. MAUDE DATABASE REPORT NUMBER: 12532135. F2 UF/IMPORTER REPORT NUMBER: 12532135 F8 DATE OF THIS REPORT: 27-SEP-2021 F13 REPORT SENT TO MANUFACTURER: YES, 29-OCT-2021 PRODUCT EVENT SUMMARY: THE VAD, (B)(6), WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT WAS ADMITTED FOR AN ISCHEMIC STROKE INVOLVING THE RIGHT SUPERIOR PARIETAL LOBE AND LEFT OCCIPITAL LOBE. THE PATIENT EXPERIENCED WORSENING APHASIA AND A DECLINE IN OVERALL FUNCTIONAL STATUS OVER A PERIOD OF TWO TO THREE WEEKS BEFORE THE PATIENT AND PATIENT'S FAMILY EXPRESSED DESIRE TO STOP ANTICOAGULATION ATTEMPTS AND TO ENTER HOSPICE CARE. 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 INSTRUCTIONS FOR USE, NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF SIMILAR ADVERSE 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

    USER FACILITY. UF/IMPORTER REPORT NUMBER: (B)(4). USER FACILITY NAME/ADDRESS/CONTACT PERSON/PHONE NUMBER (B)(6). TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: XX-SEP-2021. APPROXIMATE AGE OF DEVICE: 25 MONTHS. LOCATION WHERE EVENT OCCURRED: HOME. REPORT SENT TO MANUFACTURER: YES, XX-SEP-2021. MANUFACTURER NAME AND ADDRESS: HEARTWARE, INC., (B)(4). 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 PATIENT WAS ADMITTED FOR AN ISCHEMIC STROKE INVOLVING THE RIGHT SUPERIOR PARIETAL LOBE AND LEFT OCCIPITAL LOBE. THE PATIENT WAS INDICATED TO NOT BE ON ASPIRIN THERAPY AT THE TIME IN ORDER TO MEET INTERNATIONAL NORMALIZED RATIO (INR) GOAL. THE PATIENT EXPERIENCED WORSENING APHASIA AND A DECLINE IN OVERALL FUNCTIONAL STATUS OVER A PERIOD OF TWO TO THREE WEEKS BEFORE THE PATIENT AND PATIENT'S FAMILY EXPRESSED DESIRE TO STOP ANTICOAGULATION ATTEMPTS AND TO ENTER HOSPICE CARE. THE PATIENT DIED AT HOME AND VENTRICULAR ASSIST DEVICE (VAD) SUPPORT WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563166 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death