BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 17977604 · Received October 20, 2023

    Report

    Report Number
    2916596-2023-07495
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    February 15, 2022
    Report Date
    February 7, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. DEVICE WAS IMPLANTED AT TIME OF EVENT. ARTICLE TITLE: INTERVENTIONAL PROCEDURES FOR LEFT VENTRICULAR ASSIST DEVICE-ASSOCIATED COMPLICATIONS AUTHOR INFORMATION: LANMUELLER, P., EULERT-GREHN, J.-J., UNBEHAUN, A., KLEIN, C., HOMMEL, M., KOFLER, M., KEMPFERT, J., HOERMANDINGER, C., KAUFMANN, F., STAWOWY, P., DREYSSE, S., MULZER, J., MUELLER, M., FALK, V., SCHOENRATH, F., POTAPOV, E., & JUST, I. A. (2022). INTERVENTIONAL PROCEDURES FOR LEFT VENTRICULAR ASSIST DEVICE-ASSOCIATED COMPLICATIONS. ASAIO JOURNAL, 68(11), 1332¿1338. HTTPS://DOI.ORG/10.1097/MAT.0000000000001674. DEPARTMENT OF CARDIOTHORACIC AND VASCULAR SURGERY, GERMAN HEART CENTER BERLIN, BERLIN, GERMANY; DZHK (GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH), PARTNER SITE BERLIN, GERMANY; DEPARTMENT OF INTERNAL MEDICINE ¿ CARDIOLOGY, GERMAN HEART CENTER BERLIN, BERLIN, GERMANY; DEPARTMENT OF CARDIAC ANESTHESIOLOGY AND INTENSIVE CARE MEDICINE, GERMAN HEART CENTER BERLIN, BERLIN, GERMANY; CHARITÉ ¿ UNIVERSITÄTSMEDIZIN BERLIN, CORPORATE MEMBER OF FREIE UNIVERSITÄT BERLIN, HUMBOLDT-UNIVERSITÄT ZU BERLIN AND BERLIN INSTITUTE OF HEALTH, BERLIN, GERMANY; AND DEPARTMENT OF HEALTH SCIENCES AND TECHNOLOGY, ETH ZÜRICH, ZÜRICH, SWITZERLAND. ASAIO JOURNAL 2022. RELATED MFR #S: 2916596-2023-07496, 2916596-2023-07497. 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICES (LVAD) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. 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 (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. G AND THE HM 3 LVAS PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS MULTIPLE FORMS OF ORGAN FAILURE/DYSFUNCTION (INCLUDING RIGHT HEART FAILURE AND RENAL DYSFUNCTION), CARDIAC ARRHYTHMIA, STROKE, BLEEDING, AND INFECTION, AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM 3 LVAS. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE DEVICE WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. ADDITIONALLY, SECTION 6, "PATIENT CARE AND MANAGEMENT", LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. 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 IN THE EVENT THERE IS A RISK OF BLEEDING. THE IFU STATES THAT RIGHT VENTRICULAR FAILURE MAY DEVELOP SHORTLY AFTER PUMP IMPLANTATION AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THE IFU OUTLINES CARE INSTRUCTIONS IN REFERENCE TO PREVENTING AND CONTROLLING INFECTION. FURTHERMORE, THE PATIENT HANDBOOK PROVIDES INSTRUCTIONS ON HOW TO PREVENT INFECTION. 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 ¿INTERVENTIONAL PROCEDURES FOR LEFT VENTRICULAR ASSIST DEVICE-ASSOCIATED COMPLICATIONS¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH AORTIC REGURGITATION, ARRHYTHMIA, STROKE, RIGHT HEART FAILURE AND HEART FAILURE EXACERBATION, MULTISYSTEM ORGAN FAILURE, BLEEDING, INFECTION, PUMP THROMBOSIS, OUTFLOW GRAFT OBSTRUCTION, AND DEATH. THIS RETROSPECTIVE STUDY EVALUATED THE OUTCOMES OF INTERVENTIONAL TREATMENT PERFORMED ON PATIENTS WITH COMMON VALVULAR AND OUTFLOW GRAFT-RELATED COMPLICATIONS. DATA WAS SCREENED FOR 871 PATIENTS WHO WERE ON LEFT VENTRICULAR ASSIST DEVICE (LVAD) SUPPORT BETWEEN (B)(6) 2016 AND (B)(6) 2020; OF THESE PATIENTS, 76 HAD AN INTERVENTIONAL TREATMENT. 17 PATIENTS UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), AND 61 PATIENTS UNDERWENT A STENT IMPLANTATION INTO THEIR OUTFLOW GRAFT (OFG) TO TREAT STENOSIS. OF THE 17 TAVR PATIENTS, 9 PATIENTS WERE IMPLANTED WITH AN HM3. OF THE 61 OFG OBSTRUCTION PATIENTS, 4 PATIENTS WERE IMPLANTED WITH A HM3. OFG OBSTRUCTION WAS DIAGNOSED BY LOG FILE ANALYSIS, ECHOCARDIOGRAPHY, AND COMPUTERIZED TOMOGRAPHY (CT) SCAN. ONE PATIENT WAS NOTED TO HAVE HAD TWO SEPARATE TAVR PROCEDURES TO TREAT A TRANS-STENT LEAK, AND TWO PATIENTS WERE NOTED TO HAVE HAD BOTH A TAVR AND AN OFG INTERVENTION. TWENTY PATIENTS WERE NOTED TO HAVE RECURRENT OFG OBSTRUCTION, CUMULATING 83 INTERVENTIONS FOR 61 PATIENTS. ALL PROCEDURES UTILIZED ANTICOAGULATION BRIDGING THERAPY, INCLUDING UNFRACTIONATED HEPARIN AND DIRECT THROMBIN INHIBITORS, DEPENDING ON THE PERI-OPERATIVE INTERNATIONAL NORMALIZED RATIO (INR). THE MEDIAN LENGTH OF THE TAVR PATIENT GROUP¿S HOSPITAL STAY WAS 7.5 DAYS, WITH PROLONGED INTENSIVE CARE UNIT (ICU) STAY RANGING FROM 11 TO 28 DAYS DUE TO PNEUMONIA REQUIRING MECHANICAL VENTILATION OR ADVANCED RIGHT HEART FAILURE (RHF) REQUIRING INOTROPIC SUPPORT. RESULTS SHOWED THAT 77.8% OF PATIENTS HAD NO OR MILD HEART FAILURE SYMPTOMS FOLLOWING THEIR TAVR. OF THE 7 PATIENTS THAT EXPERIENCED PERIPHERAL EDEMA, ONLY 3 EXPERIENCED EDEMA POST-TAVR WITH LESS DIURETIC TREATMENT. TWO PATIENTS EXPERIENCED MINOR VASCULAR AND ACCESS-RELATED COMPLICATIONS POST-TAVR: ONE PATIENT REQUIRING ENDOVASCULAR STENTING OF COMMON FEMORAL ARTERY, AND THE OTHER PATIENTS EXPERIENCED AN ARTERIOVENOUS FISTULA. TWO PATIENTS EXPERIENCED A THIRD-DEGREE ATRIOVENTRICULAR BLOCK. ONE PATIENT EXPERIENCED PUMP THROMBOSIS WHICH WAS TREATED WITH INTRAVENOUS LYSIS THERAPY. POST-TAVR RHF WAS SEEN IN 3 PATIENTS; ONE PATIENT WITH RHF PASSED AWAY DURING THEIR HOSPITAL STAY. ANOTHER PATIENT PASSED AWAY DUE TO SEPSIS OF AN UNKNOWN ORIGIN. OTHER COMPLICATIONS FOR THE TAVR PATIENT GROUP INCLUDED PACEMAKER IMPLANTATION DUE TO NEW CONDUCTION ABNORMALITIES AND ACUTE KIDNEY INJURY REQUIRING RENAL REPLACEMENT THERAPY. THE MEDIAN LENGTH OF THE OFG OBSTRUCTION PATIENT GROUP¿S HOSPITAL STAY WAS 6 DAYS. COMPLICATIONS WERE OBSERVED AFTER 19 INTERVENTIONS. 9 PATIENTS EXPERIENCED BLEEDING, INCLUDING EPISTAXIS IN TWO PATIENTS WHICH REQUIRED LOCAL TAMPONADE, A HEMATOMA IN THE VASCULAR ACCESS SITE IN ONE PATIENT WHICH REQUIRED SURGICAL REVISION, AND INTRACEREBRAL BLEEDING SECONDARY TO HEMORRHAGIC STROKE IN 6 PATIENTS. OF THE 6 PATIENTS WHO EXPERIENCED INTRACEREBRAL BLEEDING, 5 PASSED AWAY. RHF OCCURRED IN 5 PATIENTS AND CONSECUTIVELY LED TO THE DEATH OF ONE PATIENT. ONE PATIENT WAS NOTED TO HAVE A DISLOCATED OFG STENT IN THEIR ABDOMINAL AORTA. TWO PATIENTS WERE NOTED TO BE ADMITTED FOR PROLONGED CARDIOGENIC SHOCK. DESPITE IMMEDIATE PUMP FLOW IMPROVEMENT, THE CONSEQUENCES OF PROLONGED END-ORGAN ISCHEMIA, DISSEMINATED COAGULATION AND COECUM PERFORATION, LED TO DEATH FOR THESE TWO PATIENTS. A TOTAL OF 8 PATIENTS PASSED AWAY POST-OFG INTERVENTION. 3 PATIENTS ALSO PASSED AWAY WITHIN 3 MONTHS AFTER DISCHARGE, SECONDARY TO NONRELATED PUMP THROMBOSIS AND GRAFT DYSFUNCTION. A TOTAL OF 11 PATIENTS UNDERWENT A HEART TRANSPLANT. OTHER COMPLICATIONS FOR THE OFG OBSTRUCTION GROUP INCLUDED ACUTE KIDNEY INJURY, PNEUMONIA, DERMATITIS, AND DELIRIUM POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064299 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| L