BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16684073 · Received April 5, 2023

    Report

    Report Number
    2916596-2023-01983
    Event Type
    Death
    Date Received
    April 5, 2023
    Date of Event
    December 1, 2020
    Report Date
    April 20, 2023
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT PROBLEM HEALTH EFFECT - CLINICAL CODE: 3261 - MULTIPLE ORGAN DYSFUNCTION SYNDROME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE: 3261 - MULTIPLE ORGAN DYSFUNCTION SYNDROME. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, THE REPORT OF RIGHT VENTRICULAR ASSIST DEVICE (RVAD) THROMBOSIS COULD NOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 DEVICES AND THE REPORTED EVENTS AND PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT (SEE ATTACHED) TITLED ¿THREE-MONTH OUTCOMES AFTER THE IMPLANTATION OF TWO HM 3 DEVICES IN TOTAL ARTIFICIAL HEART CONFIGURATION¿ INVESTIGATED THE THREE-MONTH OUTCOMES OF PATIENTS TREATED BY CARDIECTOMY AND PLACEMENT OF TWO HEARTMATE (HM) 3 LEFT VENTRICLE ASSIST DEVICES (LVADS) IN A TOTAL ARTIFICIAL HEART (TAH) CONFIGURATION. THIS RETROSPECTIVE STUDY INCLUDED 15 PATIENTS WHO UNDERWENT HM3 TAH IMPLANTATIONS, DUE TO SEVERE BIVENTRICULAR HEART FAILURE, BETWEEN (B)(6) 2017 AND (B)(6) 2020 AT THREE INTERNATIONAL INSTITUTIONS. FOLLOW UP EVALUATIONS WERE CONDUCTED THREE MONTHS AFTER THE INITIAL IMPLANTATION DURING WHICH TIME, SURVIVAL AND ADVERSE EVENT DATA WAS COLLECTED AND ANALYZED. RESULTS OF THE STUDY REVEALED THAT 9 OF THE 15 PATIENTS HAD EXPIRED THREE MONTHS AFTER THE INITIAL HM3 TAH IMPLANTATION. THE CAUSES OF DEATH INCLUDED SEPSIS RESULTING IN MULTI-SYSTEM ORGAN FAILURE (7 OUT OF 9 PATIENTS), AND NEUROLOGICAL COMPLICATIONS (2 OUT OF 9 PATIENTS). OF THE TWO PATIENTS WHO EXPERIENCED NEUROLOGICAL COMPLICATIONS, ONE SUFFERED CEREBRAL BLEEDING WHILE THE OTHER SUFFERED HYPOXIC BRAIN DAMAGE AFTER AN INGESTED THROMBUS INTO THE RVAD CAUSED THE PUMP TO STOP. EMERGENCY REMOVAL OF THE THROMBUS FORMATION WAS PERFORMED; HOWEVER, THE TIME FRAME REQUIRED TO RE-ESTABLISH THE APPROPRIATE CIRCULATION WAS TOO LONG AND RESULTED IN THE HYPOXIC STATE. FOUR PATIENTS WERE SUCCESSFULLY BRIDGED TO TRANSPLANT, AND 2 PATIENTS REMAINED ONGOING ON THE DEVICES AT THE TIME OF THE STUDY¿S PUBLICATION. THE STUDY CONCLUDED THAT THE IMPLANTATION OF TWO HM3 DEVICES IN A TAH CONFIGURATION IS A LAST RESORT AND OFF-LABEL CONCEPT IN CASES OF EXTREME BIVENTRICULAR HEART FAILURE. IN A DILIGENTLY SELECTED PATIENT COHORT, THE HM3 TAH IMPLANTATION IS A FEASIBLE METHOD TO INCREASE THE CHANCE OF SURVIVAL IN A SEVERELY ILL PATIENT COHORT AND SUCCESSFULLY BRIDGE PATIENTS TO HEART TRANSPLANTATION THAT OTHERWISE WOULD HAVE EXPIRED. THE HM3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. IT WAS REPORTED THAT THE HM3 DEVICES WERE USED AS A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WHICH IS NOT AN APPROVED INDICATION. THE HEARTMATE 3 IS INDICATED FOR LVAD SUPPORT, AND ALL LABELING, PHYSICIAN TRAINING AND CUSTOMER MARKETING MATERIALS ARE ALIGNED WITH THIS INDICATION. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS PUMP THROMBOSIS, BLEEDING, SEPSIS, MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, AND HEPATIC DYSFUNCTION), STROKE, AND DEATH AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿, INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. FURTHERMORE, SECTION 5, UNDER ¿IMPLANT PROCEDURES¿, WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "ANTICOAGULATION"), OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE FOR PATIENTS USING THE HEARTMATE 3 LVAS, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU ALSO LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ALTHOUGH ONLY SEPSIS WAS REPORTED AS A CAUSE OF DEATH, THE IFU LISTS INFECTION AS AN ADVERSE EVENT AND POTENTIAL LATE POSTIMPLANT COMPLICATION. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK ALSO PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, 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 THE PATIENT HANDBOOK. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿THREE-MONTH OUTCOMES AFTER THE IMPLANTATION OF TWO HEARTMATE 3 DEVICES IN TOTAL ARTIFICIAL HEART CONFIGURATION¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH BLEEDING, ADVERSE NEUROLOGICAL EVENTS, SEPSIS, RESPIRATORY FAILURE, MULTI-SYSTEM ORGAN FAILURE (MSOF), PUMP THROMBOSIS, PUMP STOP, AND DEATH. THIS RETROSPECTIVE STUDY EVALUATED 15 PATIENTS WHO WERE IMPLANTED WITH TWO HM3S IN A TOTAL ARTIFICIAL HEART CONFIGURATION BETWEEN JAN2017 AND AUG2020. THESE PATIENTS WERE FOLLOWED UP WITH FOR THREE MONTHS FOR ADVERSE EVENTS AND OUTCOME DATA. NO SURGICAL COMPLICATIONS OCCURRED DURING THE IMPLANTS. SIX PATIENTS REQUIRED A RE-THORACOTOMY DUE TO BLEEDING. ONE PATIENT HAD A THROMBUS FROM AN INTRAOPERATIVELY EXPLANTED EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) DRAWN INTO THE HM3 IMPLANTED AS THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD); THIS CAUSED A PUMP STOP. THE THROMBUS WAS EMERGENTLY REMOVED; HOWEVER, THE PATIENT DEVELOPED HYPOXIC BRAIN DAMAGE WHILE CIRCULATION WAS REESTABLISHED FOLLOWING THROMBUS REMOVAL. ANOTHER PATIENT ALSO REPORTEDLY EXPERIENCED RVAD THROMBOSIS AND RECEIVED LYSIS TREATMENT. 8 OUT OF 15 PATIENTS SURVIVED 30 DAYS POST-IMPLANT. 6 PATIENTS SURVIVED 3 MONTHS POST-IMPLANT. THE CAUSES OF THE 9 DEATHS WERE REPORTED AS FOLLOWS: 7 PATIENTS HAD SEPSIS THAT LED TO MSOF, AND 2 PATIENTS HAD NEUROLOGICAL DAMAGE, SPECIFICALLY A CEREBRAL BLEED AND HYPOXIA. OTHER VARIOUS ADVERSE EVENTS WERE ALSO REPORTED. BLEEDING WAS REPORTED: 3 PATIENTS EXPERIENCED EPISTAXIS, 2 PATIENTS EXPERIENCED A GASTROINTESTINAL (GI) BLEED, AND 2 PATIENTS EXPERIENCED ECMO-RELATED GROIN BLEEDING. 8 PATIENTS EXPERIENCED RESPIRATORY FAILURE. A TOTAL OF 8 PATIENTS EXPERIENCED MSOF. ONE PATIENT EXPERIENCED AN ECMO-RELATED GROIN INFECTION. ONE PATIENT EXPERIENCED DELIRIUM AND NON-OCCLUSIVE MESENTERIC ISCHEMIA. AT THE END OF FOLLOW-UP, FIVE PATIENTS WERE DISCHARGED. TWO PATIENTS REMAIN ON THE DEVICE, AND 4 UNDERWENT A SUCCESSFUL HEART TRANSPLANT PROCEDURE. THIS REPORT CAPTURES RVAD DEATHS AND PUMP THROMBOSIS THAT RESULTED IN PUMP STOP, HYPOXIC BRAIN DAMAGE, AND DEATH DUE TO HYPOXIA. RELATED MANUFACTURER REPORT NUMBERS: LVAD SERIOUS INJURY REPORT MFR # 2916596-2023-01979; LVAD DEATH REPORT MFR # 2916596-2023-01980; RVAD SERIOUS INJURY REPORT MFR # 2916596-2023-01981.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109166 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death