BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22481186 · Received July 11, 2025

    Report

    Report Number
    2916596-2025-04625
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    March 21, 2023
    Report Date
    August 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT WAS NOT PROVIDED. SECTION B3: EVENT DATE WAS ESTIMATED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT OBSTRUCTION WAS CONFIRMED VIA THE SUBMITTED IMAGES; HOWEVER, THE TYPE OF OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONFIRMED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT SUBMITTED IMAGES FOR REVIEW, WHICH CAPTURED VARIOUS ANGLES OF THE OUTFLOW GRAFT AND BEND RELIEF. THE IMAGES APPEARED TO CAPTURE A NARROWING OF THE OUTFLOW GRAFT. HOWEVER, DUE TO THE QUALITY AND ANGLE OF THE IMAGES THE TYPE OF OUTFLOW GRAFT OBSTRUCTION, COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HM3 LVAS, SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. A, ARE CURRENTLY AVAILABLE. THE IFU LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. THIS SECTION UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," 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. SECTION 5 OF THE IFU, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH." THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. 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 PATIENT WAS MANAGED FOR TWISTING OR THROMBOSIS OF THE PROXIMAL LEFT VENTRICULAR ASSIST DEVICE (LVAD) OUTFLOW CANNULA IN 2023, WHICH RESULTED IN 50% STENOSIS, CONSERVATIVELY.

    Description of Event or Problem · 0

    THE TWISTING/THROMBUS WAS CONFIRMED VIA COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2023. THE FINDINGS INCLUDED TWISTING OR THROMBOSIS OF THE PROXIMAL LVAD OUTFLOW CANNULA, WHICH RESULTED IN 50% STENOSIS, AND POSSIBLE BIO DEBRIS. FINDINGS ALSO INCLUDED CORONARY ARTERY BYPASS GRAFTING (CABG) WITH ATRETIC/OCCLUDED LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT. THERE WERE ALSO LEFT BREAST ASYMMETRIES, SO A MAMMOGRAPHIC CORRELATION WAS ADVISED. THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE EVENT AND NO RECENT CHANGES TO PUMP PARAMETERS. THE PATIENT AS ASYMPTOMATIC AND WAS TREATED WITH CONSERVATIVE MANAGEMENT. THE PATIENT WAS STABLE AT THE TIME OF THE OUTFLOW GRAFT OBSTRUCTION (OGO) AND WAS MONITORED FOR SYMPTOMS. CT SCAN RESULTS WERE PROVIDED: IMAGES WERE EVALUATED ON A 4-DIMENSIONAL DEDICATED IMAGE PROCESSING WORKSTATION IN ORDER TO EVALUATE THE INFLOW CANNULA POSITION MORE COMPREHENSIVELY. DURING BOTH SYSTOLE AND DIASTOLE, THERE WAS 0% STENOSIS OF THE ORIFICE OF THE INFLOW CANNULA. DURING BOTH SYSTOLE AND DIASTOLE, THERE WAS ALSO 0% STENOSIS OF THE PER-ORIFICE BLOOD VOLUME. THE MITRAL VALVE OPENED NORMALLY DURING DIASTOLE. THE AORTIC VALVE DID NOT OPEN DURING ANY CARDIAC PHASE, WHICH WAS TYPICAL IN THE SETTING OF AN LVAD. THE LEFT VENTRICULAR EJECTION FRACTION WAS MARKEDLY LOW AT APPROXIMATELY 15%. THERE WAS A 50% STENOSIS OF THE LUMEN OF THE PROXIMAL OUTFLOW CANNULA RELATED TO THE TWISTING OR THROMBOSIS OF THE CANNULA. THERE WAS NO OBSTRUCTION FOUND IN THE INFLOW CANNULA AND 50% STENOSIS FOUND IN THE OUTFLOW CANNULA. THE INDICATION FOR THE CT SCAN WAS PERSISTENT DIZZINESS WITH THE LVAD. THE RESULTS WERE COMPARED AGAINST A CARDIAC CT FROM (B)(6) 2022. CARDIOVASCULAR FINDINGS INCLUDED: THE RIGHT SUBCLAVIAN AND BRACHIOCEPHALIC VEINS WERE NORMAL. THE LEFT BRACHIOCEPHALIC VEIN WAS NOT OPACIFIED WITH CONTRAST MATERIAL, WHICH WAS PROBABLY RELATED TO CONTRAST TIMING FACTORS. THE LEFT CHEST WALL CARDIAC PACER/DEFIBRILLATOR WAS NOTED WITH A SINGLE LEAD TIP IN THE RIGHT VENTRICULAR APEX. THE SUPERIOR VENA CAVA (SVC) WAS NORMAL. THE INFERIOR VENA CAVA (IVC) AND HEPATIC VEINS WERE MODERATELY DILATED. THE RIGHT ATRIUM WAS MODERATELY DILATED AT 7 CM. THE RIGHT VENTRICLE WAS TOP NORMAL IN SIZE AT 5.3 CM SHORT AXIS DIAMETER. THE PULMONARY ARTERIES AND VEINS WERE NORMAL. THE LEFT ATRIUM WAS MODERATELY ENLARGED. THERE WAS MINIMAL MITRAL ANNULAR CALCIFICATION. THE LEFT VENTRICLE WAS DILATED AT 5.6 CM. THERE WAS MODERATE DIFFUSE THINNING OF THE MID AND APICAL PORTIONS OF THE SEPTUM AND OF THE BASAL PORTION OF THE LATERAL WALL. THE INFLOW CANNULA WAS IN SATISFACTORY POSITION. THE MOTOR OF THE DEVICE APPEARED GROSSLY NORMAL WITH NO SURROUNDING FLUID COLLECTION SEEN. THE METALLIC OUTFLOW CANNULA OF THE DEVICE WAS NORMAL. IMMEDIATELY DISTAL TO THE METALLIC SEGMENT, THE METALLIC SEGMENT JOINED THE FLEXIBLE OUTFLOW CANNULA, AND THERE WAS IRREGULAR MODERATE 50% STENOSIS OF THE CANNULA LUMEN. THIS AFFECTED A 5 CM-LONG SEGMENT, WHICH WAS COMPATIBLE WITH SEQUELA OF TWISTING OF THE CANNULA. THE DISTAL SEGMENT OF THE OUTFLOW CANNULA AND THE OUTFLOW CANNULA ANASTOMOSIS WERE NORMAL. THE AORTIC VALVE WAS NORMAL. THERE WAS MINIMAL AORTIC CALCIFIED PLAQUE AND THERE WAS NO DISSECTION. THE AORTA WAS NORMAL IN CALIBER. THERE WAS MINIMAL PLAQUE IN THE PROXIMAL GREAT VESSELS, WITHOUT STENOSIS. THERE WAS TREE-VESSEL NATIVE CORONARY CALCIFIED PLAQUE WITH STENTS. THE PATIENT WAS STATUS POST CABG WITH ATRETIC/OCCLUDED LIMA BYPASS, A LEFT SAPHENOUS VEIN GRAFT THAT WAS OCCLUDED AT THE ORIGIN, AND ANOTHER LEFT SAPHENOUS VEIN GRAFT THAT WAS WIDELY PATENT AND EXTENDED TO THE DIAGONAL TERRITORY. THERE WAS NO RIGHT SAPHENOUS VEIN GRAFT. THERE WAS NO SIGNIFICANT STENOSIS OF THE CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), OR PROXIMAL RIGHT RENAL ARTERY. THE OTHER ABDOMINAL AORTIC BRANCHES WERE NOT INCLUDED IN THE FIELD-OF-VIEW OF THE EXAM. OTHER FINDINGS INCLUDED: THE INFERIOR NECK WAS NORMAL. THE LUNGS AND PLEURA WERE NORMAL EXCEPT FOR DISCOID ATELECTASIS AT THE LEFT LUNG BASE, WHICH WAS RELATED TO LEFT HEMIDIAPHRAGM ELEVATION. THE ESOPHAGUS AND UPPER ABDOMINAL BOWEL WERE NORMAL AND THERE WAS MODERATE LEFT RENAL CORTICAL SCAR. THERE WAS A 1 CM SIMPLE CYST IN HEPATIC SEGMENT 2. THERE WAS A 2 CM HYPODENSE MASS IN HEPATIC SEGMENT 7, WHICH WAS INTERMEDIATE AND PROBABLY A HEMANGIOMA. THE MASSES WERE STABLE SINCE THE CT SCAN ON (B)(6) 2021. THE SKELETON WAS NORMAL EXCEPT FOR OSTEOPENIA AND THE STERNOTOMY WAS HEALED. THERE WAS A 2 CM ASYMMETRY IN THE UPPER LEFT BREAST, SERIES 6 IMAGE 105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996427 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6106411 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other