BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - APEX CORING TOOL

    MDR report key: 8784323 · Received July 12, 2019

    Report

    Report Number
    3007042319-2019-07651
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 20, 2019
    Report Date
    August 20, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: AN APICAL CORING TOOL ASSOCIATED WITH SURGICAL TOOL KIT WAS RETURNED FOR ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE SURGICAL TOOL IN RELATION TO THE REPORTED EVENT. FUNCTIONAL ANALYSIS OF THE CORING TOOL DEMONSTRATED THAT THE DEVICE EXTENDS AND RETRACTS AS INTENDED. VISUAL EXAMINATION REVEALED EVIDENCE OF CORROSION ON THE CIRCUMFERENCE OF THE REVERSE CORE CUTTER. THIS DAMAGE MAY HAVE CONTRIBUTED TO THE REPORTED INABILITY OF THE TOOL TO CORE THE HEART TISSUE, AS PERCEIVED BY THE USER. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. CONSIDERING THAT THE DEVICE MET ALL REQUIREMENTS PRIOR TO RELEASE, THE OBSERVED CORROSION LIKELY OCCURRED DURING OR AFTER USE. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MULTIPLE FACTORS, INCLUDING BUT NOT LIMITED TO DAMAGE OF THE CORING TOOL, HIGHER WALL THICKNESS OF THE LEFT VENTRICLE, AND/OR SURGICAL TECHNIQUE DURING IMPLANT. 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 TRANSPLANTATION 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE APEX CORING TOOL WAS NOT SHARP ENOUGH TO CORE THE APEX OF THE HEART. THE CORING TOOL WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577635 HEARTWARE® VENTRICULAR ASSIST SYSTEM - APEX CORING TOOL VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1318 T000038

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR