BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 23016065 · Received September 10, 2025

    Report

    Report Number
    2135147-2025-05102
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    January 1, 2011
    Report Date
    September 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF SHORT- AND LONG-TERM OUTCOMES AFTER TRANSCATHETER OR SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH CHRONIC LUNG DISEASE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR PACEMAKER, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PRIOR BALLOON VALVULOPLASTY, HYPERTENSION, CARDIAC DECOMPENSATION, CARDIOGENIC SHOCK, NEUROLOGIC DYSFUNCTION, RENAL REPLACEMENT THERAPY, PULMONARY HYPERTENSION, DIABETES, AND PERIPHERAL ARTERIAL VASCULAR DISEASE. SOME OF THE COMPLICATIONS REPORTED WERE HEMORRHAGE, ATRIAL FIBRILLATION, TRANSIENT ISCHEMIC ATTACK, MYOCARDIAL INFARCTION, STROKE, UNEXPECTED MEDICAL INTERVENTION, SURGICAL INTERVENTION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: SHORT- AND LONG-TERM OUTCOMES AFTER TRANSCATHETER OR SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH CHRONIC LUNG DISEASE: AN ANALYSIS FROM THE GERMAN AORTIC VALVE REGISTRY.

    Description of Event or Problem · 0

    THE ARTICLE, "SHORT- AND LONG-TERM OUTCOMES AFTER TRANSCATHETER OR SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH CHRONIC LUNG DISEASE: AN ANALYSIS FROM THE GERMAN AORTIC VALVE REGISTRY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO DETERMINE WHETHER THERE ARE DIFFERENCES BETWEEN PATIENTS WITH AND WITHOUT CHRONIC LUNG DISEASE (CLD) UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND SURGICAL AORTIC VALVE IMPLANTATION (SAVR) AND WHETHER TAVI OR SAVR IS MORE BENEFICIAL IN PATIENTS WITH PREEXISTING CLD. DEVICES INCLUDED IN THE STUDY WERE BOSTON SCIENTIFIC ACURATE+ NEO, SYMETIS ACURATE, EDWARDS SAPIEN 3, EDWARDS SAPIEN TRANSAPICAL, EDWARDS SAPIEN RETROFLEX 3, EDWARDS SAPIEN NOVAFLEX, JENA VALVE, MEDTRONIC CORE VALVE , MEDTRONIC ENGAGER TRANSPAPICAL, MEDTRONIC EVOLUT + PRO, SORIN CARBOMEDICS, EDWARDS PRIMA PLUS STENTLESS, CARPENTIER-EDWARDS BIO, EDWARDS PERIMOUNT, EDWARDS MAGNA + MAGNA EASE, EDWARDS INTUITY, LABCOR VALVES, ON X MECHANICAL, MEDTRONIC 3 F BIO, MEDTRONIC MECHANICAL, MEDTRONIC FREESTYLE, MEDTRONIC HANCOCK, MEDTRONIC MOSAIC, SORIN MITROFLOW, SORIN BICARBON + OTHER MECHAN. VALVES, SORIN PERCEVAL, SORIN STENTLESS, SORIN SOPRANO BIOL., SORIN CROWN BIO, SJM BIOCOR, SJM EPIC, SJM TRIFECTA, SJM MECHAN., VASCUTEK ASPIRE, AND UNKNOWN. THE ARTICLE CONCLUDED THAT PATIENTS WITH CLD UNDERGOING SAVR OR TAVI ARE GENERALLY AT HIGHER RISK FOR COMPLICATIONS OR DEATH AFTER THE PROCEDURE THAN PATIENTS WITHOUT CLD. AFTER 5 YEARS, PATIENT-REPORTED OUTCOMES WERE SIMILAR IN TAVI AND IN SAVR PATIENTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANDREAS BÖNING, DEPARTMENT OF CARDIOVASCULAR SURGERY, UNIVERSITY HOSPITAL GIESSEN, RUDOLF- BUCHHEIM-STRASSE 7, 35392 GIESSEN, GERMANY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 2014 TO 2019. A TOTAL OF 13,835 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 2775 (20.1%) RECEIVED AN ABBOTT DEVICE. IN THE SAVR GROUP, THE AVERAGE AGE WAS 75.265 YEARS AND THE MAJORITY GENDER WAS MALE. IN THE TAVI GROUP, THE AVERAGE AGE WAS 75.774 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR PACEMAKER, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PRIOR BALLOON VALVULOPLASTY, HYPERTENSION, CARDIAC DECOMPENSATION, CARDIOGENIC SHOCK, NEUROLOGIC DYSFUNCTION, RENAL REPLACEMENT THERAPY, PULMONARY HYPERTENSION, DIABETES, AND PERIPHERAL ARTERIAL VASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499489 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL UNK EPIC STENTED PORCINE HV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R| S