BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11986143 · Received June 11, 2021

    Report

    Report Number
    2916596-2021-02786
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 27, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT¿S INFECTION, AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 6.5¿ FROM THE PUMP HOUSING. A MIDDLE SEGMENT WAS RETURNED MEASURING APPROXIMATELY 2¿ AND THE REMAINING PORTION OF THE PUMP CABLE WAS ALSO RETURNED. THE MODULAR CABLE (REFER TO PI-2021-0081044-02 FOR THE COMPLETE MODULAR CABLE INVESTIGATION) WAS RETURNED PROPERLY ATTACHED TO THE INLINE CONNECTOR OF THE PUMP CABLE. THE SEALED OUTFLOW GRAFT WAS RETURNED PROPERLY ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE OUTFLOW GRAFT BEND RELIEF ENGAGED TO THE GRAFT ATTACHMENT. THE CUFF LOCK HAD BEEN DISENGAGED PRIOR TO THE PUMP BEING RETURNED FOR EVALUATION. THE APICAL CUFF WAS RETURNED DETACHED FROM THE CUFF LOCK. EVALUATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED THE PRESENCE OF TISSUE-LIKE CLOTTED BLOOD WITHIN THE LUMEN OF THE OUTFLOW GRAFT. IT WAS NOTED THAT THE OUTFLOW GRAFT WAS SUTURED SHUT IN THAT AREA. THE BLOOD WAS UNSTRUCTURED, WAS NOT ADHERED TO THE BLOOD-CONTACTING SURFACES, AND SHOWED NO EVIDENCE OF DENATURATION, SUGGESTING THAT IT WAS NOT LIKELY PRESENT DURING SUPPORT. ADDITIONALLY, THE DEPOSITION APPEARED ACUTE AND CONSISTENT WITH STAGNANT BLOOD IN THE DEVICE FOLLOWING SUPPORT THAT WOULD NOT HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE EVALUATION DID NOT REVEAL ANY EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS IN THE DEVICE. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. THE DEVICE WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 20JUL2020. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION IN THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS INFECTION (LOCALIZED, DRIVELINE, PUMP POCKET OR PSEUDO POCKET) AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU, INCLUDING CONTROLLING INFECTION. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES INSTRUCTION REGARDING HOW TO CARE FOR THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THIS DOCUMENT ALSO CONTAINS INFORMATION ABOUT PREVENTING INFECTION. SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ CONTAINS A SUBSECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ WHICH CONTAINS INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PLANNED EXPLANT OF HEARTMATE 3 FOR (B)(6) 2021 DUE TO BRIDGE TO RECOVERY (BTR) AND EJECTION FRACTION UP TO ALMOST 55%. HOWEVER, THE PATIENT HAD WORSENING DRIVELINE INFECTION. THE PLANNED EXPLANT WAS MOVED TO (B)(6) 2021, BUT WAS POSTPONED. THE PATIENT HAD AN EXPLANT ON (B)(6) 2021. ON ARRIVAL TO THE OPERATING ROOM, THE PATIENT'S DRIVELINE APPEARED TO BE PULLED OUT SIGNIFICANTLY AND MOST OF VELOUR CUFF ON THE DRIVELINE WAS EXPOSED. A SUCCESSFUL EXPLANT WAS EXECUTED. THE INFECTION APPEARED TO HAVE MIGRATED FROM THE DRIVELINE SITE THROUGH AND INTO THE PERICARDIAL SPACE. THE PUS WAS SUCTIONED AND CULTURED. THE CHEST WAS LEFT OPENED AND IT WAS PLANNED TO CLOSE THE CHEST ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879223 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7559410 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R