BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14835260 · Received June 27, 2022

    Report

    Report Number
    2916596-2022-11682
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    August 1, 2019
    Report Date
    August 16, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN NOVEMBER 2014 AND AUGUST 2019. M SALNA, ET AL. JOURNAL OF CHEST SURGERY 2022 APR 28. DOI: 10.5090/JCS.21.148. DIVISION OF CARDIAC, THORACIC, AND VASCULAR SURGERY, DEPARTMENT OF SURGERY, CENTER FOR INNOVATION AND OUTCOMES RESEARCH, DEPARTMENT OF SURGERY, AND DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY, USA 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). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LVAD DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿THE IMPACT OF INTRAPERICARDIAL VERSUS INTRAPLEURAL HEARTMATE 3 PUMP PLACEMENT ON CLINICAL OUTCOMES¿, REPORTED THE FOLLOWING INFORMATION: THE PURPOSE OF THIS STUDY WAS TO DETERMINE IF THE PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IN EITHER THE PERICARDIUM OR THORACIC CAVITY HAS A MEANINGFUL IMPACT ON OVERALL PATIENT OUTCOMES. A RETROSPECTIVE STUDY WAS CONDUCTED THAT EVALUATED 165 HEARTMATE 3 (HM3) LVAD PATIENTS WHO WERE IMPLANTED BETWEEN NOV2014 AND AUG2019. THE PATIENTS WERE CLASSIFIED BY WHETHER THEIR LVAD PLACEMENT WAS WITHIN THE PERICARDIUM (INTRAPERICARDIAL, N=84) OR IN THE LEFT PLEURAL SPACE (INTRAPLEURAL, N=81). THERE WERE READMISSIONS FOR GASTROINTESTINAL BLEEDING, LOW FLOW ALARMS, RIGHT HEART FAILURE, FOR INFECTION (INFLUENZA, PNEUMONIA, URINARY SEPSIS, WOUND INFECTIONS, DRIVELINE INFECTIONS, GENERAL INFECTIONS), CARDIAC ARRHYTHMIAS, NEUROLOGIC DYSFUNCTION, RENAL DYSFUNCTION, STROKE, RESPIRATORY FAILURE, HEMOLYSIS, MISCELLANEOUS REASONS, NON-VAD RELATED ADMISSIONS, INFLOW OR OUTFLOW OCCLUSIONS, AND DEATH. THE STUDY CONCLUDED THAT OVER THE COURSE OF 3 YEARS, THERE WAS A SIGNIFICANTLY HIGHER RATE OF READMISSION AMONG INTRAPLEURAL PATIENTS (N=180 READMISSIONS) COMPARED WITH INTRAPERICARDIAL PATIENTS (N=117). 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), REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS RIGHT HEART FAILURE, RENAL DYSFUNCTION, RESPIRATORY FAILURE, NEUROLOGICAL EVENT (NOT STROKE-RELATED), STROKE, CARDIAC ARRHYTHMIA, INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET), BLEEDING, HEMOLYSIS, AND SEPSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6, LISTS NEUROLOGICAL DYSFUNCTION AND INFECTION AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. CARE INSTRUCTIONS IN REFERENCE TO PREVENTING INFECTION ARE PROVIDED THROUGHOUT THIS IFU, INCLUDING SECTIONS TITLED "CARING FOR THE DRIVELINE EXIT SITE" AND "CONTROLLING INFECTION." HEARTMATE 3 LVAS IFU SECTION 4 ENTITLED ¿SYSTEM MONITOR¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM IS TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM, THE PUMP HAS STOPPED, THE PUMP IS NOT OPERATING PROPERLY, OR THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ EXPLAINS ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. HEARTMATE 3 LVAS PATIENT HANDBOOK SECTION 5 ENTITLED "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. 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 ¿THE IMPACT OF INTRAPERICARDIAL VERSUS INTRAPLEURAL HEARTMATE 3 PUMP PLACEMENT ON CLINICAL OUTCOMES¿ IDENTIFYING THAT HEARTMATE 3 (HM3) PLACEMENT MAY BE RELATED TO READMISSION POST-IMPLANT. THIS IS A RETROSPECTIVE STUDY THAT EVALUATED 165 HM3 PATIENTS IMPLANTED BETWEEN NOVEMBER 2014 AND AUGUST 2019. PATIENTS WERE CLASSIFIED BY WHETHER LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT WAS WITHIN THE PERICARDIUM OR IN THE LEFT PLEURAL SPACE (INTRAPLEURAL). FROM THE TOTAL OF 165, 81 HAD THE LVAD IMPLANTED WITHIN THE THORAX AND 84 HAD THE LVAD IMPLANTED WITHIN THE PERICARDIUM. OF THE 165, THERE WERE 31 READMISSIONS FOR GASTROINTESTINAL BLEEDING, 28 READMISSIONS FOR LOW FLOW ALARMS, 18 READMISSIONS FOR RIGHT HEART FAILURE, 68 READMISSIONS FOR INFECTION (41 NON-DEVICE RELATED SUCH AS INFLUENZA, PNEUMONIA, AND URINARY SEPSIS, 5 STERNAL WOUND INFECTIONS, AND 22 DRIVELINE INFECTIONS), 38 READMISSIONS FOR ARRHYTHMIA, 9 READMISSION FOR INFLOW/OUTFLOW OCCLUSION, 16 READMISSIONS FOR NEUROLOGIC REASONS, 87 READMISSIONS FOR MISCELLANEOUS REASONS, 27 GENERAL VAD-RELATED INFECTIONS, AND 41 NON-VAD RELATED ADMISSIONS. OF THE 165 PATIENTS, 31 DIED DURING THE 3 YEAR FOLLOW UP PERIOD. OVER THE COURSE OF 3 YEARS, THERE WAS A SIGNIFICANTLY HIGHER RATE OF READMISSION AMONG INTRAPLEURAL PATIENTS (N=180 READMISSIONS) COMPARED WITH INTRAPERICARDIAL PATIENTS (N=117, P<0.01).

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2022-11681 AND 2916596-2022-11683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937580 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R