BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 22289735 · Received June 19, 2025

    Report

    Report Number
    2916596-2025-03846
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 17, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. GRASSO, E., LORUSSO, R., IBRAHIM, A., ABDELHAMED, M.I., ABDALLAH, H., AND SAYIN, O.A. PERFUSION 2025, VOL. 0(0) 1¿8 © THE AUTHOR(S) 2025. DOI: 10.1177/02676591251334897. DEPARTMENT OF ADULT CARDIAC SURGERY, PRINCE SULTAN CARDIAC CENTER- AL HASSA, SAUDI ARABIA CARDIO-THORACIC SURGERY DEPARTMENT, HEART & VASCULAR CENTRE, MAASTRICHT UNIVERSITY MEDICAL CENTRE (MUMC+), MAASTRICHT, THE NETHERLANDS. CARDIOVASCULAR RESEARCH INSTITUTE MAASTRICHT (CARIM), MAASTRICHT, THE NETHERLANDS DEPARTMENT RESEARCH& BIOSTATISTICS, PRINCE SULTAN CARDIAC CENTER- AL HASSA, SAUDI ARABIA 5DEPARTMENT OF VASCULAR SURGERY, KANTONSSPITAL, AARAU, SWITZERLAND. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION E1: CUSTOMER SITE WAS (B)(6) CARDIAC CENTER. MANUFACTURER'S INVESTIGATION CONCLUSION: IT WAS REPORTED IN THE RESEARCH ARTICLE TITLED, ¿HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE SYSTEM IN PATIENTS WITH GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY¿, THAT ONE OF THE PATIENTS UNDERWENT HEART TRANSPLANTATION. NO DEVICE RELATED ISSUES WERE REPORTED FOR THIS PATIENT. THE SERIAL NUMBER OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM IN USE WAS NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE RESEARCH ARTICLE TITLED, ¿HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE SYSTEM IN PATIENTS WITH GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY¿, GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY IS A GENETIC ENZYMATIC DISORDER THAT AFFECTS MILLIONS OF PEOPLE WORLDWIDE AND CHARACTERIZED BY HEMOLYSIS UNDER OXIDATIVE STRESS. LEFT VENTRICULAR ASSIST DEVICES (LVADS) HAVE SUBSTANTIALLY ENHANCED SURVIVAL AND QUALITY OF LIFE FOR INDIVIDUALS WITH ADVANCED HEART FAILURE. HOWEVER, THEIR USE IS ASSOCIATED WITH THE RISK OF HEMOLYSIS, THROMBOSIS, AND EMBOLIC EVENTS. THESE RISKS MAY BE HEIGHTENED IN PATIENTS WITH GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY. THIS CASE SERIES OF FIVE PATIENTS WITH G6PD DEFICIENCY AND CHRONIC HEART FAILURE RECEIVING DURABLE VADS REPRESENTS THE FIRST REPORTED EXPERIENCE WITH A SUGGESTED MANAGEMENT PATHWAY FOR THIS COMBINATION IN PATIENTS UNDERGOING LVAD IMPLANTATION. IT IS ESTIMATED THAT ABOUT 400 MILLION PEOPLE ARE AFFECTED BY G6PD DEFICIENCY WORLDWIDE.14 THIS GENETIC CONDITION IS INHERITED AS AN X-LINKED RECESSIVE STATE AND PRESENTS ONE OF THE MOST FREQUENTLY ENCOUNTERED RED-CELL ENZYMOPATHIES. THE MAJOR INTEREST IN THE G6PD-DEFICIENT STATE RESULTS FROM THE ASSOCIATED HEMOLYTIC ANEMIA RESULTING FROM OXIDATIVE STRESS.15,16 IT IS WORTH MENTIONING THAT HEMOLYSIS-INDUCED THROMBOTIC EVENTS IN G6PD PATIENTS OCCUR WHEN HEMOLYSIS RELEASES FREE HEMOGLOBIN INTO THE BLOODSTREAM. THIS FREE HEMOGLOBIN BINDS TO HAPTOGLOBIN, FORMING METHEMOGLOBIN. WHEN HAPTO GLOBIN IS SATURATED, FREE METHEMOGLOBIN CAN PRECIPITATE IN THE MICROCIRCULATION. THESE PRECIPITATES CAN ACTIVATE PLATELETS AND CLOTTING FACTORS, LEADING TO THROMBUS FORMATION. AS MENTIONED, MECHANICAL CIRCULATORY DEVICES HAVE BEEN SHOWN TO INDUCE, IN SOME OCCASION, MARKED SHEAR STRESS AND, SUBSEQUENTLY, BLOOD ELEMENTS DAMAGE. A RETROSPECTIVE, OBSERVATIONAL, SINGLE-CENTER STUDY WAS CONDUCTED ON ADULT (>18 YEARS OF AGE) PATIENTS WITH G6PD DEFICIENCY, WHO UNDERWENT LVAD IMPLANTATION USING THE HM3 LVAD BETWEEN 2017 AND 2022. HEMOLYSIS-RELATED INVESTIGATION AND FINDINGS AS WELL AS IN-HOSPITAL OUTCOME WERE ASSESSED. HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICES (LVADS) WERE SUCCESSFULLY IMPLANTED IN FIVE ADULT PATIENTS WITH G6PD DEFICIENCY, INCLUDING ONE INDIVIDUAL WITH ASSOCIATED SICKLE CELL TRAIT (SCT). THERE WERE NO MAJOR COMPLICATIONS OR FATALITIES DURING THE HOSPITALIZATION PERIOD. THE AVERAGE FOLLOW-UP DURATION WAS 30 MONTHS (MEAN 30.4 ± 13). DURING THE FOLLOW-UP PERIOD, TWO PATIENTS DIED (2916596-2025-03895 AND 2916596-2025-03852), TWO LVADS WERE EXPLANTED, AND ONE PATIENT RECEIVED A HEART TRANSPLANT. NO INSTANCES OF MACROSCOPIC HEMOLYSIS WERE OBSERVED THROUGHOUT THE FOLLOW-UP PERIOD. HEMOLYSIS HAS BECOME AN INCREASINGLY RECOGNIZED COMPLICATION OF LVADS SUPPORT. THE INCIDENCE OF HEMOLYSIS VARIES (5%-18%) DEPENDING ON THE DEFINITION AND AMONG DIFFERENT GENERATIONS OF LVADS, BEING SLIGHTLY HIGHER IN CONTINUOUS-FLOW THAN TO PULSATILE DEVICES. CAREFUL CLINICAL AND LABORATORY MONITORING REMAIN THE CORNERSTONE OF PATIENT MANAGEMENT IN THIS RESPECT. G6PDDEFICIENCYIS ONE OF THE COMMON HUMAN ENZYME DEFICIENCY DISORDERS WITH VARIABLE PREVALENCE IN THE MIDDLE EAST AND MEDITERRANEAN COUNTRIES. THIS CONDITION MIGHT REPRESENT A RISK FACTOR OF EXACERBATION OF HEMOLYSIS IN LVAD RECIPIENTS. THE STUDY DEFINED HEMOLYSIS ACCORDING TO THE INSTITUTIONAL PROTOCOL, WHICH INCLUDES PATIENTS WITH THE FOLLOWING 3 PARAMETERS: UNEXPLAINED ANEMIA (HGB250U/L) IN THE ABSENCE OF OBVIOUS BLEEDING, TOTAL BILIRUBIN(=1MG/DL) AND HIGH LDH (>250U/L). PLASMA FREE HGB DATA WAS NOT AVAILABLE FOR MOST PATIENTS, AS THEY WERE REFERRED TO A LABORATORY AND WERE NOT ROUTINELY MONITORED DURING THE STUDY PERIOD. THE ONSET OF MACROSCOPIC HEMATURIA WAS ADDITIONALLY EVALUATED. PERIOPERATIVELY BLOOD GAS CHECKS WERE REPETITIVELY EXECUTED TO DETECT ACIDOSIS AND HYPERGLYCEMIA, WHICH ARE POTENTIAL PRECIPITATING FACTORS FOR HEMOLYSIS. ALL PATIENTS UNDERWENT CARDIAC SURGERY THROUGH FULL MEDIAN STERNOTOMY AND RECEIVED THE VAD SYSTEM HM3. IMMEDIATELY AFTER COMING OFF CPB, THE PATIENT URINE WAS CHECKED REGARDING ANY SIGNS OF HEMATURIA. POSTOPERATIVELY, ANTICOAGULATION WAS STARTED WITH LOW MOLECULAR WEIGHT HEPARIN ON THE ICU AFTER 12¿24 HOURS, DEPENDING ON BLEEDING AMOUNT. ANTIPLATELET DRUGS AND ORAL ANTICOAGULANTS WERE STARTED ON THE SECOND POSTOPERATIVE DAY, UNLESS BLEEDING COMPLICATIONS OCCUR. THERE WAS NEITHER MORTALITY NOR COMPLICATION WITHIN 30 DAYS, 3 MONTHS AND 6 MONTHS POSTOPERATIVELY. THERE WERE NO IN-HOSPITAL DEATHS. IN CONCLUSION, WHILE THE STUDY WAS LIMITED IN SIZE, LVADS SEEM SAFE FOR G6PD-DEFICIENT PATIENTS AND OFFER SIGNIFICANT CLINICAL BENEFITS. LARGER STUDIES ARE NEEDED TO CONFIRM THIS AND ASSESS LONG-TERM INTERACTIONS. RESULTS SUGGEST THAT G6PD DEFICIENCY DOES NOT NEGATIVELY IMPACT POST-IMPLANT OUTCOMES OR INCREASE THE RISK OF HEMOLYSIS-RELATED COMPLICATIONS IN LVAD PATIENTS. NO SIGNIFICANT INCREASE IN HEMOLYSIS BIOMARKERS WAS OBSERVED DURING IN-HOSPITAL FOLLOW-UP OR POST-DISCHARGE, AND NO MAJOR HEMOLYSIS-RELATED COMPLICATIONS OCCURRED IN THESE PATIENTS. THIS CARDIAC CENTER'S LVAD PROGRAM WAS STOPPED AND THERE WAS NO TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496719 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention