BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 16559720 · Received March 16, 2023

    Report

    Report Number
    2916596-2023-01562
    Event Type
    Death
    Date Received
    March 16, 2023
    Date of Event
    January 1, 2018
    Report Date
    March 12, 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
    OTHER
    Health Professional
    N

    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 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBER, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, IS 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU) IS CURRENTLY AVAILABLE. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE RIGHT HEART FAILURE AND DEATH MAY HAVE BEEN RELATED TO THE OFG OBSTRUCTION. THE RIGHT HEART FAILURE AND DEATH WERE PREVIOUSLY REPORTED UNDER MANUFACTURER REFERENCE NUMBER 2916596-2023-01521 AND WILL BE REPORTED WITH THE OFG OBSTRUCTION UNDER MANUFACTURER REFERENCE NUMBER 2916596-2023-01562. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBER, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, IS NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU), DOCUMENT (B)(4), REV. G IS CURRENTLY AVAILABLE. MULTIPLE ORGAN FAILURES/DYSFUNCTION, BLEEDING, AND DEATH ARE LISTED AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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. SECTION 6 OF THE IFU, UNDER ¿ANTICOAGULATION¿, PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-01521.

    Description of Event or Problem · 0

    EVENT DATE HAS BEEN ESTIMATED. 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 GASTROINTESTINAL (GI) BLEEDING, RENAL IMPAIRMENT, HEART FAILURE EXACERBATION, RIGHT HEART FAILURE, AND OUTFLOW GRAFT (OFG) OBSTRUCTION. CASE 5 OF THE ARTICLE INVOLVED A PATIENT IMPLANTED IN 2018 WHO SUFFERED FROM A RECURRENT GI BLEED AND WAS HOSPITALIZED DUE TO A HEMORRHAGIC KIDNEY CYST THAT REQUIRED SURGICAL INTERVENTION AND PERMANENT DIALYSIS. A POSTOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A PROXIMAL OFG STENOSIS GREATER THAN 50%. SINCE THE PATIENT WAS FREE FROM HEART FAILURE SYMPTOMS AND NO ALARMS WERE RECORDED, NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS DISCHARGED. SIX MONTHS LATER, THE PATIENT WAS ADMITTED FOR HEART FAILURE, SEVERE RIGHT HEART FAILURE, DYSPNEA AND ASCITES DESPITE CHRONIC HEMODIALYSIS. AN INTRAOPERATIVE ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED A SEVERE OFG OBSTRUCTION OF THE PROXIMAL TRACT. TWO OVERLAPPING STENTS AND AN ENDOPROSTHESIS WERE IMPLANTED WHICH RESOLVED THE ISSUE. THE PATIENT WAS IMPLANTED WITH AN IMPELLA FOR TEMPORARY MECHANICAL CIRCULATORY SUPPORT FOR RIGHT HEART FAILURE; HOWEVER, RIGHT HEART FAILURE PERSISTED AND THE PATIENT DIED 24 DAYS LATER DUE TO LIVER AND END-ORGAN FAILURE.

    Description of Event or Problem · 0

    EVENT DATE HAS BEEN ESTIMATED. 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 GASTROINTESTINAL (GI) BLEEDING, RENAL IMPAIRMENT, HEART FAILURE EXACERBATION, RIGHT HEART FAILURE, AND OUTFLOW GRAFT (OFG) OBSTRUCTION. CASE 5 OF THE ARTICLE INVOLVED A PATIENT IMPLANTED IN 2018 WHERE AN INTRAOPERATIVE ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED A SEVERE OFG OBSTRUCTION OF THE PROXIMAL TRACT. TWO OVERLAPPING STENTS AND AN ENDOPROSTHESIS WERE IMPLANTED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936546 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death