BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 12455225 · Received September 10, 2021

    Report

    Report Number
    2916596-2021-04865
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    March 30, 2021
    Report Date
    November 22, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE OUTFLOW GRAFT OBSTRUCTION WAS CONFIRMED THROUGH THE COMPUTED TOMOGRAPHY IMAGES PROVIDED BY THE ACCOUNT, HOWEVER, THE EXTENT OF THE OBSTRUCTION COULD NOT BE DETERMINED BY THE PICTURES ALONE. A SPECIFIC CAUSE FOR THE REPORTED OBSTRUCTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE EXAMINATION OF THE SUBMITTED COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) SCANS SHOWED A SUSPECTED OBSTRUCTION IN THE OUTFLOW GRAFT UNDERNEATH THE OUTFLOW GRAFT BEND RELIEF. IT WAS REPORTED THAT THE PATIENT HAS A SUSPECTED OUTFLOW GRAFT OCCLUSION. COMPUTED TOMOGRAPHY (CT) SCANS WERE TAKEN ON (B)(6) 2021 AND THE PATIENT WAS SCHEDULE FOR AN EXPLORATION OF THE OUTFLOW GRAFT ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT A CT IMAGE WAS TAKEN SHOWING COMPRESSION OF THE OUTFLOW GRAFT UNDERNEATH THE BEND RELIEF. DURING THE REVISION SURGERY, BIODEBRIS WAS FOUND AROUND THE PROXIMAL END OF THE OUTFLOW GRAFT LOCATED UNDER THE BEND RELIEF ON THIS PATIENT. THE PATIENT HAD STABLE AND APPROPRIATE PUMP PARAMETERS DURING THE CASE WITHOUT ANY CHANGE AFTER THE BEND RELIEF WAS CUT AND IT WAS CLEANED OUT. THE TEAM LOOKED WITH A SONOSITE IN THE OUTFLOW GRAFT AND FELT THERE WAS NO CONCERN FOR CLOT IN THE OUTFLOW GRAFT ITSELF. ADDITIONALLY, UPON ENTERING THE PATIENT¿S CHEST, THE SURGEON WAS ABLE TO SEE THE RIDGES IN THE OUTFLOW GRAFT THAT ARE NORMALLY COMPLETELY COVERED WHEN THE OUTFLOW GRAFT IS FULLY SCREWED IN PLACE. ALTHOUGH THE SURGEON IS UNSURE HOW MUCH HE TIGHTENED THE CLIP, HE CONFIRMED THAT THE OUTFLOW GRAFT WAS TIGHTENED BACK DOWN AND A HM 3 OUTFLOW GRAFT CLIP WAS PLACED. THE PATIENT¿S PARAMETERS REMAINED STABLE AND THE PATIENT ONLY EXPERIENCED SYMPTOMS OF FATIGUE AND LESS ENDURANCE. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HM3 LVAS IFU CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND CAUTIONS THE USER NOT TO ROTATE/TWIST THE GRAFT. THE IFU 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. THIS DOCUMENT STATES THAT FOLLOWING THE DE-AIRING PROCESS, THE BEND RELIEF MUST BE SLID OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING UNTIL IT ENGAGES INTO PLACE, AND 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. 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 (B)(6) 2015. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. SECTION D4: THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# G140113. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 SYSTEM CONTROLLER IS 00813024013235.

    Description of Event or Problem · 0

    THE PATIENT WAS REQUIRING INCREASED DOSES OF DIURETICS AND HAD A RIGHT HEART CATHETER WITH SPEED STUDY. THE SPEED WAS INCREASED WITHOUT ANY CHANGES HEMODYNAMICALLY. THE PROGRAM THEN GOT A CTA THAT SHOWED COMPRESSION OF THE OUTFLOW GRAFT UNDERNEATH THE BEND RELIEF. DURING THE EXPLORATION PROCEDURE, THE OUTFLOW GRAFT WAS NOTED TO BE SLIGHTLY UNSCREWED FROM THE OUTLET WHEN THE SURGEON ENTERED THE CHEST. THE OUTFLOW GRAFT WAS TIGHTENED AND AN OUTFLOW GRAFT CLIP WAS PLACED. THERE WAS BIODEBRIS NOTED AROUND THE PROXIMAL END OF THE OUTFLOW GRAFT UNDER THE BEND RELIEF, BUT THERE WAS NOT CONCERN FOR CLOT IN THE OUTFLOW GRAFT ITSELF. THE PATIENT HAD STABLE AND APPROPRIATE PUMP PARAMETERS DURING THE CASE WITHOUT ANY CHANGE AFTER THE BEND RELIEF WAS CUT AND IT WAS CLEANED OUT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED OUTFLOW GRAFT OCCLUSION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE ON (B)(6) 2021, AND THE PATIENT WAS SCHEDULED FOR AN EXPLORATION OF THE OUTFLOW GRAFT ON (B)(6) 2021. THE PATIENT HAD SYMPTOMS OF FATIGUE. THE PATIENT HAD A REVISION OF THE OUTFLOW GRAFT IN THE OPERATING ROOM. THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350465 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R