BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14835501 · Received June 27, 2022

    Report

    Report Number
    2916596-2022-11683
    Event Type
    Malfunction
    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
    Product Problem
    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 (B)(6) 2014 AND (B)(6) 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 (B)(6) 2014 AND (B)(6) 2019. 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 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 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. THIS SECTION FURTHER WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. SECTION 1 OF THE IFU LISTS DEVICE THROMBUS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION AND PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. 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 NUMBER: 2916596-2022-11681 AND 2916596-2022-11682.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750949 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown