BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8372004 · Received February 26, 2019

    Report

    Report Number
    2916596-2019-00918
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    September 9, 2017
    Report Date
    May 9, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSIONS: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ~ 1 YEARS AND 8 MONTHS. THE DEVICE REMAINS IN USE AND WAS NOT AVAILABLE FOR EVALUATION. THIS TYPE OF EVENT HAS BEEN PREVIOUSLY INVESTIGATED. REFERENCE DOCUMENT (B)(4). COMPLAINT DATA IS REVIEWED PERIODICALLY PER THE QUALITY DATA REVIEW PROCESS (QS WORK INSTRUCTION # (B)(4)). QUALITY DATA REVIEWS (QDR) ARE CONDUCTED ON PRODUCTION AND POST PRODUCTION SIGNALS TO EVALUATE SPECIFIC BUSINESS AREAS AND PRODUCTS AND ENSURE THE EFFECTIVENESS OF THESE BUSINESS AREAS AND PRODUCTS INCLUDING CONFORMITY TO PRODUCT REQUIREMENTS. THIS IS DONE BY PERIODIC REVIEW OF KEY PERFORMANCE INDICATORS AND OBJECTIVES. QDR INFORMATION, AS APPLICABLE, FEEDS INTO CAPA REQUESTS. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS AND NO FURTHER EVENTS HAVE BEEN REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RELAPSE OF INTESTINAL HEMORRHAGE. VIDEOCAPSULE EXPLORATION WAS PERFORMED ON (B)(6) 2017. FIBROSCOPY AND COLONOSCOPY WERE PERFORMED ON (B)(6) 2017. PROCTOLOGY CONSULTATION: NO SOURCE OF BLEEDING WAS FOUND ON (B)(6) 2018. PLANNED COLONOSCOPY WAS PERFORMED ON (B)(6) 2018. ON (B)(6) 2018, INTESTINAL HEMORRHAGE WAS REPORTED. ON (B)(6) 2018, INTESTINAL HEMORRHAGE WAS REPORTED. THE PATIENT WAS HOSPITALIZED, CHANGES WERE MADE TO MEDICATION, AND BLOOD TRANSFUSION WAS PERFORMED. NO ALARMS WERE REPORTED FOR THE EVENT. NO FURTHER INFORMATION WAS PROVIDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163734 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524INT 5997888

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R