BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 25113512 · Received May 7, 2026

    Report

    Report Number
    3004478276-2026-00140
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 7, 2026
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS ATTEMPTING TO RETRIEVE FURTHER INFORMATION FROM THE HEALTHCARE FACILITY, AND WILL SUBMIT A FOLLOW-UP REPORT UPON RECEIPT OF NEW DETAILS.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A NOTIFICATION FROM THE MHRA CONCERNING A DEATH CASE INVOLVING A PATIENT IMPLANTED WITH A PERCEVAL VALVE (UNKNOWN MODEL AND SERIAL NUMBER) ON (B)(6) 2021 (IMPLANT DATE TO BE CONFIRMED). PATIENT MEDICAL HISTORY INCLUDED TYPE 2 DIABETES MELLITUS, HYPERTENSION AND PERIPHERAL VASCULAR DISEASE. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2026 THE PATIENT WAS ADMITTED TO HOSPITAL WITH HEART FAILURE SYMPTOMS AND DIAGNOSED WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION WITH REDUCED EJECTION FRACTION (15 - 20% AT BEDSIDE ECHO, 40 - 45% AT DEPARTMENTAL ECHO). DEGENERATION OF THE PERCEVAL VALVE WAS IDENTIFIED, WITH SEVERE STENOSIS AND REGURGITATION. THE PATIENT WAS TREATED WITH DIURETICS, STABILISED ON MEDICAL THERAPY AND DISCHARGED ON (B)(6) 2026 WITH PLAN FOR OUTPATIENT CT AND DISCUSSION IN STRUCTURAL TEAM MDTM, FOR CONSIDERATION OF TAVI PROCEDURE. ON (B)(6) 2026, THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH, SEVERE EXERCISE INTOLERANCE, AND CLINICAL SIGNS OF DECOMPENSATED HEART FAILURE, INCLUDING PULMONARY OEDEMA, HYPOTENSION, AND FLUID OVERLOAD. INVESTIGATIONS REVEALED ATRIAL FIBRILLATION WITH PVCS (PREMATURE VENTRICULAR COMPLEXES), MARKEDLY ELEVATED BNP, RISING TROPONIN LEVELS CONSISTENT WITH ACUTE CORONARY SYNDROME, AND EVIDENCE OF CARDIORENAL SYNDROME. TREATMENT WITH INTRAVENOUS DIURETICS AND ANTITHROMBOTIC THERAPY WAS INITIATED. ON (B)(6) 2026, THE PATIENT WAS DEEMED UNSUITABLE FOR SURGICAL VALVE REPLACEMENT DUE TO SEVERE BIVENTRICULAR DYSFUNCTION, AND EVALUATION FOR TAVI WAS PLANNED, WITH CT PERFORMED ON (B)(6) 2026. ON (B)(6) 2026, CARDIOLOGY REVIEW CONFIRMED SEVERE AORTIC STENOSIS WITH ACUTE KIDNEY INJURY. THE PATIENT DETERIORATED RAPIDLY, WITH NEWS SCORE 7, PULMONARY OEDEMA, AND PROGRESSIVE RENAL AND HEPATIC FAILURE. ALTHOUGH NO CLEAR INFECTIVE FOCUS WAS IDENTIFIED, A POSSIBLE INFECTION OF UNKNOWN SOURCE WAS SUSPECTED, AND EMPIRICAL ANTIBIOTIC THERAPY WITH CO-AMOXICLAV WAS COMMENCED. LATER THAT DAY, THE PATIENT DEVELOPED SIGNIFICANT HEPATIC AND RENAL DYSFUNCTION. GIVEN THE ABSENCE OF CONFIRMED INFECTION AND CONCERN REGARDING WORSENING LIVER INJURY, CO-AMOXICLAV WAS DISCONTINUED. OVERNIGHT INTO (B)(6) 2026, THE PATIENT DEVELOPED PERSISTENT HYPOTENSION, RISING LACTATE, METABOLIC ACIDOSIS, HYPERKALAEMIA, AND ANURIA, CONSISTENT WITH REFRACTORY CARDIOGENIC SHOCK AND MULTI-ORGAN FAILURE, DESPITE CRITICAL CARE INPUT. AN EMERGENCY SALVAGE TAVI WAS UNDERTAKEN FOR SEVERE BIOPROSTHETIC VALVE FAILURE WITH COMBINED SEVERE AORTIC STENOSIS AND REGURGITATION. DURING THE PROCEDURE, THE PATIENT SUFFERED ASYSTOLIC CARDIAC ARREST, REQUIRING PROLONGED MECHANICAL CPR, BALLOON VALVULOPLASTY, AND VALVE IMPLANTATION. ALTHOUGH THE VALVE WAS SUCCESSFULLY IMPLANTED ANATOMICALLY, THERE WAS NO HAEMODYNAMIC OR METABOLIC RECOVERY, AND RESUSCITATION WAS ULTIMATELY DISCONTINUED DUE TO IRREVERSIBLE MULTI-ORGAN FAILURE. THE MANUFACTURER HAS RECEIVED A DETAILED REPORT FROM MHRA, WHICH HAS BEEN INCLUDED IN THE MANUFACTURER'S RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213487 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death