BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14317239 · Received May 7, 2022

    Report

    Report Number
    2916596-2022-10758
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 28, 2022
    Report Date
    April 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D AND H4 PRODUCT INFORMATION CHANGED TO HEARTMATE 3 LVAS IMPLANT KIT. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED VIDEO CONFIRMED THE REPORTED BLOOD LEAK; HOWEVER, NO DEVICE-RELATED ISSUES WERE IDENTIFIED DURING THE EVALUATION OF THE HEARTMATE 3 MINI APICAL CUFF, LOT NUMBER: 8093911. A DIRECT CAUSE FOR THE REPORTED BLOOD LEAK COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE MINI APICAL CUFF WAS RETURNED IN USED CONDITION. THE MINI CUFF SHOWED SUTURE HOLES ALONG THE FELT RING. THE SILICONE ALONG THE BOTTOM EDGE OF THE METAL RING APPEARED UNREMARKABLE. THE MINI CUFF WAS MEASURED USING A MICROSCOPIC ELECTRONIC MEASURING TOOL. THE INNER DIAMETER OF THE METAL FRAME OF THE MINI CUFF WAS FOUND TO BE WITHIN SPECIFICATIONS. THE MINI CUFF WAS INSERTED INTO A TEST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD), AND THE MINI CUFF ENGAGED WITHIN THE CUFF LOCK WITHOUT DIFFICULTY. THE MINI CUFF APPEARED TO BE CORRECTLY SEATED. ROTATING THE MINI CUFF WITHIN THE ENGAGED CUFF LOCK FOUND THAT THE CONNECTION FELT SECURE. THE CONNECTION WAS LUBRICATED WITH A SALINE SOLUTION AND NO LEAKAGE WAS OBSERVED BETWEEN THE O-RING OF THE MOTOR HOUSING AND THE MINI CUFF. THE PATIENT REMAINS ONGOING ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS FOR (B)(6) SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. ADDITIONALLY, REVIEW OF THE DEVICE HISTORY RECORDS FOR THE MINI APICAL CUFF LOT NUMBER: 8093911 SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 MINI APICAL CUFF KIT INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THE IFU IN THE ¿SURGICAL PROCEDURES¿ SECTION, EXPLAINS HOW TO PREPARE THE MINI APICAL CUFF AND THE APICAL CUFF HOLDER FOR USE. SECTION ¿DIRECTIONS FOR USE¿ EXPLAINS HOW TO SECURE THE MINI APICAL CUFF TO THE VENTRICLE. THIS SECTION ALSO INSTRUCTS THE USER THAT THE MINI APICAL CUFF SHOULD BE AFFIXED ONLY BY THE SEW-THEN-CUT METHOD AND PLEDGETS SHOULD BE PLACED NO MORE THAN ONE AND A HALF CENTIMETERS FROM THE EDGE OF THE FELT. AFFIXING THE MINI APICAL CUFF USING METHODS OTHER THAN THE PRESCRIBED TECHNIQUE CAN LEAD TO CHALLENGES ENGAGING THE SLIDE LOCK MECHANISM. IN ADDITION, THIS SECTION DESCRIBES HOW TO INSERT THE PUMP INTO THE VENTRICLE. THIS IFU CAUTIONS: WHEN SEWING THE MINI APICAL CUFF TO THE EXTERIOR OF THE HEART, THE FELT SURFACE SHOULD HAVE A FLAT OR CONVEX SHAPE. THIS IS SO THAT THE PUMP AND SLIDE LOCK MECHANISM CAN ENGAGE THE METAL RING ON THE MINI APICAL CUFF. THE SUTURE KNOTS SHOULD NOT INTERFERE WITH THE CONNECTION. IF A SEALING AGENT IS USED ON OR NEAR THE MINI APICAL CUFF, IT SHOULD NOT INTERFERE WITH THE SLIDE LOCK MECHANISM. IF THE SLIDE LOCK MECHANISM ON THE HEARTMATE 3 LVAD FAILS TO ENGAGE, DO NOT MAKE FURTHER ATTEMPTS TO ENGAGE UNTIL RETRACTING THE SLIDE LOCK MECHANISM. EVIDENCE OF THE SLIDE LOCK MECHANISM FAILING TO ENGAGE WILL BE EITHER VISUAL EVIDENCE OF THE YELLOW ¿WINGS,¿ OR A TACTILE FEEL OF THREE RIDGES VERSUS ONE. THE SLIDE LOCK WILL NOT ENGAGE THE MINI APICAL CUFF UNLESS INITIALLY FULLY RETRACTED. IF DIFFICULTY PERSISTS WHEN ENGAGING THE SLIDE LOCK MECHANISM, THE LVAD SHOULD BE REMOVED FROM THE MINI APICAL CUFF TO VISUALIZE WHAT MIGHT BE PREVENTING THE CONNECTION. THE MINI APICAL CUFF MUST BE AFFIXED TO THE LEFT VENTRICLE ONLY BY THE SEW-THEN-CUT METHOD. USING THE CUT-THEN-SEW METHOD MAY LEAD TO CHALLENGES WITH ENGAGING THE SLIDE LOCK MECHANISM. THE MINI APICAL CUFF MUST BE AFFIXED TO THE LEFT VENTRICLE ONLY BY THE PRESCRIBED TECHNIQUE IN THIS DOCUMENT TO AVOID CHALLENGES WITH ENGAGING THE SLIDE LOCK MECHANISM. CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MINI APICAL CUFF WAS IMPLANTED USING THE CORE-THEN-SEW METHOD. FOUR CARDINAL SUTURES AND A RUNNING SUTURE WERE PLACED. THE HEART WAS CORED WITH A CORING KNIFE AND THE PUMP WAS CONNECTED AND THE HEMOSTASIS WAS CHECKED. THERE WAS SMALL BLEEDING OBSERVED FORM UNDERNEATH THE PUMP. THE PUMP WAS REORIENTED TO SEE IF THE BLEEDING WOULD STOP, BUT WAS UNSUCCESSFUL. THE PUMP WAS REMOVED AND THE SUTURE WAS ADDED TO THE AREA OF THE OBSERVED BLEEDING AND THE SUTURES WERE SECURED TO MAKE SURE THEY WOULD NOT INTERFERE WITH THE LOCKING MECHANISM. THE CUFF HOLDER WAS THEN USED TO CHECK THE HOMEOSTASIS. THE PUMP WAS RECONNECTED AND THERE WAS STILL BLEEDING UNDERNEATH THE PUMP. THE PUMP WAS AGAIN REMOVED AND THE MINI APICAL CUFF WAS REPLACED WITH A REGULAR APICAL CUFF AND THE PUMP WAS RECONNECTED. HEMOSTATIC CONNECTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079149 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 8230872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R