BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9689255 · Received February 10, 2020

    Report

    Report Number
    2916596-2020-00444
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    May 1, 2019
    Report Date
    March 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B1: CORRECTION. SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT OBSTRUCTION OF THE OUTFLOW GRAFT (OFG) WITH STENOSIS WAS OBSERVED ON A CT IN (B)(6) OF 2019. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER DIAGNOSIS. FURTHER IMAGING DIAGNOSTICS PRESENTED HIGH GRADE OBSTRUCTION OF THE OFG IN THE GRAFT PROTECTOR. THE OFG WAS STENTED ON (B)(6) 2019, USING A CARDIAC CATHETER. ACCORDING TO THE ACCOUNT, THE EVENT RESOLVED ON (B)(6) 2019. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS. THE HM3 LVAS IFU CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND EXPLAINS HOW TO ATTACH THE SEALED OUTFLOW GRAFT TO THE AORTA. THE ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP SUBSECTION INSTRUCTS THE USER TO VERIFY THAT THE 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. THE DE-AIRING THE PUMP SUBSECTION EXPLAINS THAT WHEN THE PUMP IS IN PLACE AND THE SEALED OUTFLOW GRAFT ANASTOMOSES IS COMPLETED, RESIDUAL AIR MUST BE COMPLETELY EVACUATED FROM THE DEVICE BLOOD CHAMBER PRIOR TO INITIATING DEVICE ACTIVATION. WHEN DE-AIRING IS COMPLETED, SLIDE THE BEND RELIEF OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING UNTIL IT ENGAGES INTO PLACE. THIS SECTION WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 30JUN2016. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. THE SURGICAL PROCEDURES SECTION OF THE HM3 IFU CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND EXPLAINS HOW TO ATTACH THE SEALED OUTFLOW GRAFT TO THE AORTA. THE ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP SUBSECTION INSTRUCTS THE USER TO VERIFY THAT THE 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. THE DE-AIRING THE PUMP SUBSECTION EXPLAINS THAT WHEN THE PUMP IS IN PLACE AND THE SEALED OUTFLOW GRAFT ANASTOMOSES IS COMPLETED, RESIDUAL AIR MUST BE COMPLETELY EVACUATED FROM THE DEVICE BLOOD CHAMBER PRIOR TO INITIATING DEVICE ACTIVATION. WHEN DE-AIRING IS COMPLETED, SLIDE THE BEND RELIEF OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING UNTIL IT ENGAGES INTO PLACE. THIS SECTION WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. 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 · 1

    EVENT DATE IS ESTIMATED. 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 OBSTRUCTION OF THE OUTFLOW GRAFT (OFG) WITH STENOSIS WAS OBSERVED ON A CT IN MAY OF 2019. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER DIAGNOSIS. FURTHER IMAGING DIAGNOSTICS PRESENTED HIGH GRADE OBSTRUCTION OF THE OFG IN THE GRAFT PROTECTOR. OFG WAS STENTED ON (B)(6) 2019 USING A CARDIAC CATHETER. THE PATIENT DOES NOT EXPRESS ANY COMPLAINTS. THE EVENT RESOLVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153531 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5502819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R