BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 16548159 · Received March 15, 2023

    Report

    Report Number
    2916596-2023-01523
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    November 17, 2022
    Report Date
    March 13, 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

    AUTHOR 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 THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 88197). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PURPOSE OF THIS STUDY WAS TO OBSERVE PATIENTS SUPPORTED BY THE HEARTMATE (HM) 3 LVAD THAT DEVELOPED AN OUTFLOW GRAFT OBSTRUCTION AFTER 607-1250 DAYS OF SUPPORT, DURING PROLONGED ANTITHROMBOTIC THERAPY. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HM 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HM 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. G AND THE HM 3 PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS STROKE AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM 3 LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "ANTICOAGULATION") OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE FOR PATIENTS USING THE HM 3 LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. 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. FURTHERMORE, SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. 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

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

    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, INTRACRANIAL HEMORRHAGE, AND OUTFLOW GRAFT (OFG) OBSTRUCTION. CASE 3 OF THE ARTICLE INVOLVED A PATIENT ADMITTED DUE TO HEART FAILURE AND DYSPNEA. THE PATIENT¿S PUMP PARAMETERS WERE NORMAL AND NO SIGNS OF HEMOLYSIS WERE OBSERVED. THE PATIENT¿S MEDICAL THERAPY WAS INCREASED AND THEIR PUMP SPEED WAS INCREASED WHICH DID NOT IMPROVE THEIR SYMPTOMS. THE PATIENT WAS NOTED TO BE INOTROPE DEPENDENT. A COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN REVEALED A 60MM LONG DEFECT OF THE PROXIMAL TRACT OF THE OFG WITH A MAXIMUM THICKNESS OF 9MM. THE PATIENT WAS BROUGHT TO THE OR FOR AN ENDOVASCULAR OFG TREATMENT. AN INTRAOPERATIVE INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED A CRITICAL OFG STENOSIS GREATER THAN 50%. THE PATIENT WAS STENTED WITHOUT AN ANGIOGRAPHY, LEADING TO OFG CANALIZATION. THE PATIENT¿S POSTOPERATIVE COURSE WAS COMPLICATED BY AN INTRACRANIAL HEMORRHAGE IN THE RIGHT PARIETO-TEMPORO-OCCIPITAL REGION ON POSTOPERATIVE DAY 10; A NEUROSURGICAL INTERVENTION WAS PERFORMED FOR INTRACRANIAL HYPERTENSIONS. THE PATIENT RECOVERED AND WAS DISCHARGED 25 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769057 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H