BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 12045328 · Received June 22, 2021

    Report

    Report Number
    3004478276-2021-00176
    Event Type
    Injury
    Date Received
    June 22, 2021
    Report Date
    August 5, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE WAS NOT EXPLANTED AND THE SERIAL NUMBER IS UNKNOWN, NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND THE MEDICAL JUDGMENT RECEIVED, THERE IS NOT ENOUGH EVIDENCE TO SUSPECT A DEVICE MALFUNCTION WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRESENCE OF THE PERIVALVULAR LEAK, INITIALLY REPORTED, WAS NOT CONFIRMED AT THE TIME OF THE FOLLOW UP; ON THE CONTRARY, THE PHYSICIAN CONFIRMED THAT THE PERCEVAL VALVE IS WORKING, WITH NO PLANS FOR RE-INTERVENTION. FURTHERMORE, THE PATIENT'S DECOMPENSATION (BILATERAL PLEURAL EFFUSION) WAS REPORTEDLY ATTRIBUTED TO BE A POST THORACOTOMY SYNDROME, AND WAS NOT ATTRIBUTED TO THE LEAKAGE WHICH WAS ASSESSED AS A FLOW FROM THE LVOT TO THE RA AND RV AND NOT HEMODYNAMICALLY SIGNIFICANT BY THE PHYSICIAN. AS SUCH, THERE IS NO EVIDENCE OF A SERIOUS INJURY FOR THE PATIENT CAUSED BY THE DEVICE, NOR OF A DEVICE MALFUNCTION. SHOULD ANY FURTHER INFORMATION BE RECEIVED AT A LATER STAGE, THE MANUFACTURER WILL TAKE FURTHER ACTIONS AS DEEMED APPLICABLE AND PROVIDE A FOLLOW UP REPORT AS REQUIRED.

    Description of Event or Problem · 0

    A PATIENT RECEIVED A PERCEVAL XL AORTIC VALVE DUE TO SEVERE AORTIC VALVE STENOSIS ON (B)(6) 2021. AN EXTENSIVE DECALCIFICATION WAS REPORTED. ON (B)(6) 2021, A PARAVALVULAR LEAK WAS IDENTIFIED. THE PATIENT WAS DECOMPENSATED (BILATERAL LARGE PLEURAL EFFUSIONS). IN THE TRANSTHORACIC ECHO, THERE WERE 2 JETS - ONE ORIGINATING FROM THE LVOT/BASAL SEPTUM INTO THE RIGHT ATRIUM AND ONE TOWARD THE RIGHT VENTRICLE WITH A SYSTOLIC/DIASTOLIC FLOW PATTERN. IN THE TEE STUDY, IT WAS VERIFIED THAT THERE ARE 2 JETS ORIGINATING FROM THE SINUS OF VALSALVA (BASICALLY CORRESPONDING TO THE TTE STUDY). AS REPORTED BY THE PHYSICIAN, THE PATIENT MAY NOT DECOMPENSATE BECAUSE OF THE JET. ADDITIONAL INFORMATION WAS RECEIVED IDENTIFYING THE FOLLOWING. REGARDING THE DEVICE FUNCTIONALITY AFTER THE IMPLANT, IT WAS CONFIRMED THAT THE DEVICE IS WORKING. THE LEAKAGE WAS ALREADY VISIBLE BUT DIFFERENTLY INTERPRETED (PARAVALVULAR VS TRICUSPID REGURGITATION) PRIOR TO THE POSTOPERATIVE EVALUATION. AS REPORTED, THE JETS WERE IDENTIFIED IN THE TTE STUDY PERFORMED ON (B)(6) 2021, THE TEE STUDY ((B)(6) 2021) VERIFIED THE FINDINGS. THE DIFFERENCE THAT WAS FOUND IN THE TEE WAS THAT THE ORIGIN OF THE JETS WAS TRULY FROM THE LVOT AND NOT THE BASAL SEPTUM (WHICH WOULD HAVE BEEN A GERBODE DEFECT). QUANTIFICATION OF THE 2 LEAKAGES WAS NOT POSSIBLE. OVERALL THE FLOW FROM THE LVOT TO THE RA AND RV WAS PRESENT IN DIASTOLE AND SYSTOLE. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE LEAK WAS DEFINED AS NOT TO BE HEMODYNAMICALLY RELEVANT AS THE LV WAS NOT DILATED AND THE PATIENT UNTIL NOW IS NOT DECOMPENSATED (NEXT APPOINTMENT IS IN 3 MONTHS). THE PRESSURE GRADIENTS COULD NOT BE WELL EVALUATED. OTHER CAUSES WERE NOT FOUND. AS REPORTED, THE LEAKAGE PARTIALLY CONTRIBUTED TO THE STATE OF THE PATIENT. OVERALL THE PATIENT'S AS IS REPAIRED, LV FUNCTION IS NORMAL, RV FUNCTION IS NORMAL. THE PRIMARY CAUSE FOR THE PLEURAL EFFUSIONS WAS ATTRIBUTED TO BE A POST THORACOTOMY SYNDROME, NOT THE LEAKAGE. THE PATIENT WAS DISCHARGED ON (B)(6) AFTER RECOMPENSATION WITH SMALL RESIDUAL PLEURAL EFFUSIONS AND A MINOR PULMONARY CONGESTION (CHEST RADIOGRAPH). REINTERVENTION IN CASE OF PATIENTS AGE AND THE RECOMPENSATED STATE WITH DIURETICS (SPIRONOLACTON 50, FUROSEMID 80MG) IS NOT PLANNED (UNTIL NOW).

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PATIENT RECEIVED A PERCEVAL XL AORTIC VALVE DUE TO SEVERE AORTIC VALVE STENOSIS. AN EXTENSIVE DECALCIFICATION WAS REPORTED. AFTER THE PROCEDURE, A PARAVALVULAR LEAK WAS IDENTIFIED. THE PATIENT WAS DECOMPENSATED (BILATERAL LARGE PLEURAL EFFUSIONS). IN THE TRANSTHORACIC ECHO, THERE WERE 2 JETS - ONE ORIGINATING FROM THE LVOT/BASAL SEPTUM INTO THE RIGHT ATRIUM AND ONE TOWARD THE RIGHT VENTRICLE WITH A SYSTOLIC/DIASTOLIC FLOW PATTERN. IN THE TEE STUDY, IT WAS VERIFIED THAT THERE ARE 2 JETS ORIGINATING FROM THE SINUS OF VALSALVA (BASICALLY CORRESPONDING TO THE TTE STUDY). AS REPORTED BY THE PHYSICIAN, THE PATIENT MAY NOT DECOMPENSATE BECAUSE OF THE JET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936274 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVS27

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other