BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5081226 · Received September 16, 2015

    Report

    Report Number
    3007042319-2015-02210
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN APICAL CORING TOOL WAS RETURNED FOR ANALYSIS ALONG WITH A SECTION OF THE CUTTER EDGE MEASURING APPROXIMATELY 1.5 CM IN LENGTH. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE SURGICAL TOOL IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT OF CORING TOOL "DAMAGE" WAS CONFIRMED AS THE RETURNED DEVICE SHOWED EXTENSIVE DAMAGE (FRACTURE) AT THE CUTTER EDGE OF THE REVERSE CORE. DIMENSIONAL VERIFICATION, FUNCTIONAL TEST, MATERIAL IDENTIFICATION, HARDNESS, AND DHR REVIEW DID NOT IDENTIFY DEVIATIONS FROM SPECIFICATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. VISUAL EVIDENCE SHOWS EVIDENCE OF CORROSION; HOWEVER, IT CANNOT BE DETERMINED WHETHER THE CORROSION WAS A PRE-EXISTING CONDITION PRIOR TO USE. IN ADDITION SEM ANALYSIS SHOWS THE CUTTER EDGE BENT OUTWARD SUGGESTING BENDING FORCES WERE APPLIED TO THE UNIT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MULTIPLE FACTORS MAY HAVE PLAYED A ROLE ON THE REPORTED EVENT, INCLUDING BUT NOT LIMITED TO; EXCESSIVE FORCE APPLIED TO THE UNIT, DAMAGE INDUCED PRIOR TO USE, AND/OR DEFECTIVE COMPONENT. A MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY IDENTIFIED FROM THE INVESTIGATION PERFORMED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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. THE INSTRUCTIONS FOR USE (IFU) STATES THAT ALL THE TOOLS AND ACCESSORIES USED DURING IMPLANTATION ARE FOR SINGLE-USE ONLY. IT FURTHER STATES TO EXAMINE ALL COMPONENTS, INCLUDING THE SURGICAL TOOLS, FOR DAMAGE, CORROSION OR ANY ABNORMALITIES THAT MIGHT AFFECT THE SAFETY OR FUNCTIONALITY OF THE TOOLS. IF ANY ABNORMALITIES ARE NOTED PLEASE USE THE APPROPRIATE BACKUP SUPPLIES. IFU OUTLINES PROPER USE AND TECHNIQUES FOR USE OF THE APICAL CORING TOOL. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT DURING SURGERY THE "IMPLANT TEAM DID EXPERIENCE DIFFICULTY GOING THROUGH THE APEX AFTER THE CRUCIATE INCISION HAD ALREADY BEEN MADE." DUE TO THE PATIENT HISTORY OF "MYOCARDIAL INFARCTION AND A VERY THICK MYOCARDIUM." THE PATIENT WAS IMPLANTED USING THE "DIAPHRAGMATIC APPROACH (ALONG THE SURFACE OF THE DIAPHRAGM)." DURING THE COURSE OF THE SURGERY THE "CORING TOOL BLADE FRACTURED AND SEPARATED." "ONLY HALF OF THE FRACTURED STRIP WAS RECOVERED." "THE SURGICAL TEAM WAS UNABLE TO LOCATE THE OTHER HALF." "THE PATIENT HAS HAD POST-OPERATIVE X-RAYS BUT THEY HAVE NOT SHOWN THE MISSING PIECE." IT WAS REPORTED THAT THE PATIENT DID "NOT EXPERIENCE ANY INJURY AND WAS OK." NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613525 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1