BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16538717 · Received March 14, 2023

    Report

    Report Number
    2916596-2023-01515
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    November 17, 2022
    Report Date
    March 11, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE HEARTMATE (HM) 3 DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿EXTRINSIC OUTFLOW GRAFT FLOW OBSTRUCTION IN PATIENTS WITH HM3 LEFT VENTRICULAR ASSIST DEVICE (LVAD)¿, EVALUATED HM3 LVAD PATIENTS THAT DEVELOPED AN OUTFLOW GRAFT OBSTRUCTION (OGO) AFTER 607 ¿ 1250 DAYS OF SUPPORT DURING PROLONGED ANTITHROMBOTIC THERAPY. OF NOTE, PATIENT 4 REQUIRED HOSPITALIZATION FOR HEART FAILURE APPROXIMATELY 930 DAYS AFTER THEIR INITIAL IMPLANT. THE PATIENT EXPERIENCED SYMPTOMS INCLUDING DYSPEPSIA, PERIPHERAL OEDEMA, AND PULMONARY CONGESTION. FOLLOWING AN ECHOCARDIOGRAPHIC DIAGNOSIS OF SEVERE AORTIC REGULATION, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WAS CONDUCTED WITH THE PERSPECTIVE TO PERFORM A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) PROCEDURE. A PROXIMAL OGO WAS DOCUMENTED WITH A LENGTH OF APPROXIMATELY 5 CENTIMETERS (CM), A MAXIMUM THICKNESS OF 9 MILLIMETERS (MM), AND A RESIDUAL LUMEN OF 6MM X 16MM. THE PATIENT UNDERWENT THE TAVI PROCEDURE AND COULD BE WEANED FROM INOTROPES AND MECHANICAL VENTILATION. BECAUSE THE PATIENT RECOVERED FROM HEART FAILURE, IT WAS DECIDED TO MONITOR THE CLINICAL COURSE AND TO FOLLOW-UP THE OGO WITH A ¿WATCHFUL WAITING¿ CARE APPROACH. AFTER 487 DAYS OF FOLLOW-UP, THE PATIENT HAD NO RECURRENCE OF HEART FAILURE. THE HM3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HM3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HM3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, "INTRODUCTION", LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE LVAD WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. SECTION 5 OF THE IFU, ALSO 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 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 OF THE IFU, 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 OF THE IFU, 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 5 OF THE PATIENT HANDBOOK AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. A SECTION ON ¿HANDLING EMERGENCIES¿ IS ALSO PROVIDED IN THIS DOCUMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    ARTICLE INFORMATION: AJELLO S ET AL. EXTRINSIC OUTFLOW GRAFT FLOW OBSTRUCTION IN PATIENTS WITH HEARTMATE3 LVAD. ARTIF ORGANS. 2022;00:1¿5. HTTPS://DOI.ORG/10.1111/AOR.14450 SAN RAFFAELE SCIENTIFIC INSTITUTE, MILAN, ITALY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿EXTRINSIC OUTFLOW GRAFT FLOW OBSTRUCTION IN PATIENTS WITH HEARTMATE3 LVAD¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH HEART FAILURE EXACERBATION, PERIPHERAL EDEMA, AORTIC REGURGITATION, AND OUTFLOW GRAFT (OFG) OBSTRUCTION. CASE 4 OF THE ARTICLE INVOLVED A PATIENT WHO REQUIRED HOSPITALIZATION FOR HEART FAILURE, DYSPEPSIA, PERIPHERAL EDEMA, AND PULMONARY CONGESTION. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED THAT REVEALED SEVERE AORTIC REGURGITATION. A COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN WAS PERFORMED WITH THE PERSPECTIVE TO PERFORM A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI); AN OFG OBSTRUCTION WAS DOCUMENTED WITH A LENGTH OF 5CM, MAXIMUM THICKNESS 9MM AND A RESIDUAL LUMEN 6MM X 16MM. THE PATIENT UNDERWENT A TAVI AND WAS WEANED FROM INOTROPES AND MECHANICAL VENTILATION. NO INTERVENTION WAS PERFORMED FOR THE OFG OBSTRUCTION AS THE PATIENT HAD RECOVERED FROM THEIR HEART FAILURE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719971 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Required Intervention| H