BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS MINI APICAL CUFF KIT

    MDR report key: 8408243 · Received March 11, 2019

    Report

    Report Number
    2916596-2019-00908
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 12, 2019
    Report Date
    May 21, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013082
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. THE CENTER REPORTED THAT THE SURGEON HAD DIFFICULTY WITH THE MINI APICAL CUFF. IT WAS REPORTED THAT THE IFU WAS NOT FOLLOWED DURING IMPLANT AND THE SURGEON COULD NOT LOCK ON THE HM3 PUMP TO THE CUFF ONCE SUTURED TO THE HEART. THE SURGEON HAD TO REMOVE THIS CUFF FROM THE HEART AND USE A DIFFERENT APICAL CUFF. IT WAS SPECIFIED THAT INSTEAD OF SUTURING THE CUFF ON PER THE IFU, THE SURGEON USED MULTIPLE INTERRUPTED PLEDGETED SUTURES THAT WERE ALSO FARTHER AWAY THAN THE RECOMMENDED DISTANCE FROM THE CUFF. THE SURGEON ALSO USED LARGER FELT SECTIONS ON THE HEART AS WELL AS BIO GLUE. THIS CAUSED SEVERE BUNCHING OF HEART TISSUE AND THE FELT RING PORTION OF THE CUFF TO BUNCH AND GO CONCAVE KEEPING THE PUMP FROM LOCKING ON. IT WAS ALSO NOTED THAT THERE WERE A LOT OF ADDITIONAL KNOTS TAKING UP SPACE ON TOP OF THE FELT AND THESE KNOTS WERE PROBLEMATIC FOR THE LOCKING MECHANISM ON THE PUMP. IT WAS REPORTED THAT THE PATIENT WAS STABLE AT THE TIME OF THE EVENT. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. THE SURGICAL PROCEDURES SECTION OF THE HM3 MINI APICAL CUFF KIT IFU EXPLAINS HOW TO PREPARE THE MINI APICAL CUFF AND THE APICAL CUFF HOLDER FOR USE. THE DIRECTIONS FOR USE SECTION OF THIS DOCUMENT 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. THIS SECTION ALSO STATED THAT IF A SEALING AGENT IS USED ON OR NEAR THE MINI APICAL CUFF, ENSURE THAT IT DOES NOT INTERFERE WITH THE SLIDE LOCK MECHANISM. THE HEARTMATE 3 LVAS IFU WARNS THE USER THAT A COMPLETE BACKUP SYSTEM MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT INSTEAD OF SUTURING THE CUFF ON PER IFU (INSTRUCTIONS FOR USE) THE SURGEON USED MULTIPLE INTERRUPTED PLEDGETED SUTURES THAT WERE ALSO FARTHER AWAY THAN THE RECOMMENDED DISTANCE FROM THE CUFF. THE SURGEON ALSO USED LARGER FELT SECTIONS ON THE HEART AS WELL AS BIO GLUE. THIS CAUSED SEVERE BUNCHING OF HEART TISSUE AND THE FELT RING PORTION OF THE CUFF TO BUNCH AND GO CONCAVE KEEPING THE PUMP FROM LOCKING ON. ALSO THERE WERE A LOT OF ADDITIONAL KNOTS TAKING UP SPACE ON TOP OF THE FELT AND THESE KNOTS WERE PROBLEMATIC FOR THE LOCKING MECHANISM ON THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF DEVICE: 1 DAY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH MINI APICAL CUFF. INSTRUCTIONS FOR USE WAS NOT FOLLOWED DURING IMPLANT AND COULD NOT LOCK ON THE HM3 PUMP TO THE CUFF ONCE SUTURED TO THE HEART. THE SURGEON HAD TO REMOVE THIS CUFF FROM THE HEART AND USE A DIFFERENT APICAL CUFF. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203265 HEARTMATE 3 LVAS MINI APICAL CUFF KIT HEARTMATE 3 LVAS MINI APICAL CUFF KIT DSQ THORATEC CORPORATION 10005877 6688701 00813024013082

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention