BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 14830216 · Received June 27, 2022

    Report

    Report Number
    3007042319-2022-05501
    Event Type
    Death
    Date Received
    June 27, 2022
    Date of Event
    July 9, 2021
    Report Date
    August 10, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. USER FACILITY: UF/IMPORTER REPORT NUMBER: (B)(4). USER FACILITY NAME/ADDRESS: (B)(4) HOSPITAL. CONTACT PERSON: PHONE NUMBER: DATE USER FACILITY BECAME AWARE OF THE EVENT: (B)(6) 2021. TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: 28-JUL-2021. APPROXIMATE AGE OF DEVICE: 3 YRS, 10 MNT. (B)(4). LOCATION WHERE EVENT OCCURRED: HOME. REPORT SENT TO MANUFACTURER: YES, 02-MAY-2022. MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC ADDL: (B)(4). CITY: (B)(4). STATE: (B)(4). ZIP: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, 694765 LEAD, IMPLANTED (B)(6) 2010, 305U27, TISSUE VALVE, IMPLANTED (B)(6) 2008. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) WAS NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT PERFORMED SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED HIGH POWER/FLOW EVENT WAS NOT CONFIRMED. INFORMATION RECEIVED FROM THE SITE REVEALED, IN ADDITION TO THE HIGH POWER/FLOW EVENT, THAT THE PATIENT CALLED THE CLINIC WITH COMPLAINTS OF FIVE POUNDS OF WEIGHT GAIN. THE NEXT DAY, THE PATIENT WAS ADMITTED FOR CHEST PAIN, NAUSEA, VOMITING, HEMATURIA. THE PATIENT WAS IN CHRONIC VENTRICULAR FIBRILLATION WITH SEVERAL SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). THE PATIENT HAD HIGH LACTATE DEHYDROGENASE (LDH) AND HIGH PLASMA FREE HEMOGLOBIN (PFHG). THE PATIENT WAS COMPLIANT WITH ASPIRIN AND COUMADIN AND WAS GIVEN HEPARIN. ADDITIONALLY, THE PATIENT WAS ON HOSPICE CARE DUE TO RIGHT VENTRICULAR (RV) DYSFUNCTION AND INTRACTABLE VENTRICULAR TACHYCARDIA (VT). THE PATIENT EXPIRED IN THE SETTING OF PRESUMED PUMP THROMBOSIS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED HIGH POWER/FLOW EVENT INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, PATIENT RELATED FACTORS, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. PER THE INSTRUCTIONS FOR USE, VENTRICULAR DYSFUNCTION, CARDIAC ARRHYTHMIA, DEVICE THROMBUS, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF AN VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF THROMBUS, VENTRICULAR DYSFUNCTION, OR CARDIAC ARRHYTHMIA 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC WITH COMPLAINTS OF INCREASED VENTRICULAR ASSIST DEVICE (VAD) FLOWS AND POWERS AND FIVE POUNDS OF WEIGHT GAIN. THE NEXT DAY, THE PATIENT WAS ADMITTED FOR CHEST PAIN, NAUSEA, VOMITING, HEMATURIA, AND VAD ALARMS ASSOCIATED WITH AN INCREASE IN VAD FLOW/POWER. THE PATIENT WAS IN CHRONIC VENTRICULAR FIBRILLATION WITH SEVERAL SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) VALUES NOTED. LACTATE DEHYDROGENASE (LDH) WAS FOUND TO BE 310 WITH NORMAL RANGE BEING BETWEEN 100-200, THE PLASMA FREE HEMOGLOBIN (PFHG) WAS 911 WITH NORMAL RANGE BEING 20-70, AND THE VAD FLOWS WERE IN THE 9'S AND THE POWERS IN THE 6'S WITH NORMAL RANGE BEING IN THE 4'S FOR BOTH FLOWS AND POWERS. THE PATIENT WAS COMPLIANT WITH ASPIRIN (ASA) AND COUMADIN, AND WAS GIVEN HEPARIN. IT WAS NOTED THAT THE PATIENT WAS ON HOSPICE CARE DUE TO RIGHT VENTRICLE (RV) DYSFUNCTION AND INTRACTABLE VENTRICULAR TACHYCARDIA (VT). THE PATIENT WAS NOT A CANDIDATE FOR VAD EXCHANGE AND EXPIRED IN THE SETTING OF PRESUMED PUMP THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813946 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death DDMB1D1 ICD