BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 8042817 · Received November 6, 2018

    Report

    Report Number
    2015691-2018-04557
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 12, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    PANNUS OVERGROWTH, OR HOST TISSUE, IS CONSIDERED TO BE A FORM OF NON-STRUCTURAL VALVE DYSFUNCTION. THE GROWTH OF HOST TISSUE ON THE SEWING RING IS EXPECTED AND IS A NATURAL PART OF THE HEALING REACTION TO PROSTHESIS IMPLANTATION. HOST TISSUE IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, PANNUS CAN HAVE BOTH BENEFICIAL AND HARMFUL EFFECTS DEPENDING ON THE AMOUNT OF GROWTH. A SMALL AMOUNT OF HOST TISSUE GROWTH OVER THE SUTURE LINE IS NEEDED TO FORM A NON-THROMBOGENIC SURFACE AND COMPLETE THE HEALING PROCESS AFTER VALVE IMPLANTATION. IN CONTRAST, IF THERE IS AN EXCESSIVE AMOUNT OF PANNUS GROWTH, IT CAN EXTEND ONTO THE CUSP SURFACES LEADING TO THICKENING OF THE CUSPS, LEAFLET IMMOBILITY, ELEVATED GRADIENTS AND STENOSIS. HOST TISSUE GROWTH CAN ALSO CONTRIBUTE TO CUSP RETRACTION OR CURLING RESULTING IN VALVULAR REGURGITATION. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH CANNOT BE DETERMINED AT THIS TIME. IN THIS CASE, A DEFINITIVE ROOT CAUSE FOR PANNUS GROWTH COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IT WAS REPORTED THAT THIS PATIENT WITH A 33MM PERICARDIAL MITRAL VALVE, IMPLANTED FOR 10 YEARS AND THREE (3) MONTHS, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE MITRAL STENOSIS. TEE SHOWED SEVERE PANNUS FORMATION AND A 0.6CM LEAK INFERIOR TO THE MITRAL VALVE SUTURE RING ON THE LAA SIDE. SHE WAS ALSO FOUND TO HAVE TWO MOBILE AREAS OF INCREASED ECHOGENICITY ON THE VENTRICULAR SIDE ADHERENT TO THE AORTIC VALVE LEAFLETS OF UNCLEAR ETIOLOGY. A TMVR WAS SUCCESSFULLY PERFORMED WITH A 29MM EDWARDS TRANSCATHETER VALVE. THE PATIENT HAD SIGNIFICANT IMPROVEMENT IN STATUS OVERALL AND WAS AMBULATING HALLS WITH STABLE LABS, VITALS, AND VOLUME STATUS. SHE WAS DISCHARGED HOME IN GOOD CONDITION ON POD #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880687 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P33MM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R