BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 14043161 · Received April 7, 2022

    Report

    Report Number
    3007042319-2022-04615
    Event Type
    Death
    Date Received
    April 7, 2022
    Date of Event
    September 28, 2021
    Report Date
    June 7, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. USER FACILITY, UF/IMPORTER REPORT NUMBER: (B)(4). USER FACILITY NAME/ADDRESS: (B)(6) ; CONTACT PERSON: (B)(6); PHONE NUMBER: (B)(6); DATE USER FACILITY BECAME AWARE OF THE EVENT: UNK; TYPE OF REPORT: INITIAL; DATE OF THIS REPORT: (B)(6) 2022; APPROXIMATE AGE OF DEVICE: UNK; (B)(4) ; LOCATION WHERE EVENT OCCURRED: HOSPITAL NICU; REPORT SENT TO MANUFACTURER: YES, (B)(6) 2022; MANUFACTURER NAME AND ADDRESS: HEARTWARE INC. (B)(4) . 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) WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS NOT CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT PRESENTED AS PALE, FATIGUED, AND NAUSEATED, AND RECURRENCE OF THROMBUS WAS SUSPECTED. THE PATIENT SUBSEQUENTLY DIED. 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 LOW FLOW EVENT INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. PER THE INSTRUCTIONS FOR USE THROMBUS AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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 PRESENTED TO THE EMERGENCY DEPARTMENT PALE, FATIGUED AND NAUSEATED WITH LOW FLOWS AND INTERMITTENTLY PULSATILE. NON-INVASIVE BLOOD PRESSURE, MEAN ARTERIAL PRESSURE 84, VENTRICULAR ASSIST DEVICE (VAD) ACTIVELY ALARMING LOW FLOWS, FLOWS SHOW ABRUPT DROP IN THE LAST 12-16 HOURS, NOW 0.3, POWER CURRENTLY AT 2.9. IT WAS NOTED THAT LOW FLOWS HAVE BEEN PRESENT SINCE LAST PREVENTIVE MAINTENANCE WITH NO IMPROVEMENT DESPITE INCREASE OF FLUIDS. RECURRENCE OF INLET THROMBUS WAS ALSO SUSPECTED, FEW DAYS LATER THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341357 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Death