BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11739632 · Received April 28, 2021

    Report

    Report Number
    2916596-2021-02216
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    March 25, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q118-MCS-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT TWISTING AND OBSTRUCTION WERE CONFIRMED THROUGH THE EVALUATION OF THE SUBMITTED IMAGES. A SPECIFIC CAUSE FOR THE REPORTED TWISTING AND OBSTRUCTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW EVENTS; HOWEVER, IT WAS REPORTED THAT THESE EVENTS WERE DUE TO THE OUTFLOW GRAFT TWISTING. THE SUBMITTED IMAGE OF THE OUTFLOW GRAFT (OFG) DISPLAYED TWISTING OF THE OFG. THE CT IMAGE OF THE OFG DISPLAYED EXTRINSIC OBSTRUCTION OF THE OFG. A PHOTO OF THE RECONSTRUCTED OFG WAS SUBMITTED WHICH SHOWED THE CORRECTION OF THE OFG TWIST AND OBSTRUCTION. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6) 2021 14:18:08 THROUGH (B)(6) 2021 09:49:48. TRANSIENT LOW FLOW EVENTS WERE OBSERVED THROUGHOUT THE LOG FILE, RESULTING IN 15 LOW FLOW ALARMS. THE ACCOUNT REPORTED THAT THIS FLOW REDUCTION WAS DUE TO OUTFLOW GRAFT TWISTING AND OBSTRUCTION. DESPITE THESE EVENTS, THE PUMP APPEARED TO FUNCTION AS INTENDED. THE CONTROLLER PERIODIC AND LVAD EVENT AND PERIODIC LOG FILES CAPTURED THE PUMP OPERATING AS INTENDED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. NO PRODUCT AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 24JUL2017. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS SECTION ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF ONCE THE VENT NEEDLE HAS BEEN REMOVED FROM THE SEALED OUTFLOW GRAFT AND LEAKS HAVE BEEN RULED OUT. SECTION 1 LISTS THE OUTFLOW GRAFT CLIP AS A REQUIRED COMPONENT FOR IMPLANT. SECTION 5, FURTHER INSTRUCTS THE USER TO ¿ATTACH THE OUTFLOW GRAFT CLIP TO PREVENT POST-OPERATIVE OUTFLOW GRAFT TWISTING¿ AND WARNS THAT FAILURE TO INSTALL THE OUTFLOW GRAFT CLIP SO THAT IT IS FLUSH WITH THE BEND RELIEF CAN ALLOW GRAFT TWISTING OR ABRASION WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS BLEEDING, GRAFT OCCLUSION, THROMBOSIS, AND/OR DEATH. 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.

    Additional Manufacturer Narrative · 0

    H9 - FA-Q118-MCS-1, FA-Q124-HF-1. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL WELL AND REPORTED TO THE HOSPITAL ON (B)(6) 2021. LOG FILES SHOWED A LOW FLOW AND LOW PULSATILITY INDEX (PI). THE PATIENT WAS SENT IN FOR FURTHER INVESTIGATION. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED A POSSIBLE OBSTRUCTION JUST ABOVE THE BEND RELIEF. REOPERATION AND OUTFLOW GRAFT INSPECTION WAS SCHEDULED FOR (B)(6) 2021. THE OPERATION WAS DONE ON (B)(6) 2021 AND SHOWED AN OUTFLOW GRAFT TWIST JUST ABOVE THE BEND RELIEF. A LOT OF JELLY MASS WAS FOUND UNDERNEATH THE BEND RELIEF. THE OUTFLOW GRAFT WAS UNTWISTED BY THE SURGEONS. GOOD FLOW WAS RESTORED. NO BYPASS WAS NEEDED, NO OUTFLOW GRAFT WAS REPLACED, AND NO OUTFLOW GRAFT CLIP WAS PLACED AFTERWARDS. THE PATIENT WAS RECOVERING AFTER THE OUTFLOW RECONSTRUCTION AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633331 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6073132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown