BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2863833 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18800
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 9, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). "PERICARDIAL LEAFLET WITH MILD FIBROUS PANNUS. SURFACE RECENT THROMBI IS ALSO NOTED." ADDITIONAL MANUFACTURER NARRATIVE: BASED ON THE FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE SUBJECT DEVICE HAS BEEN DISCARDED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE PATHOLOGY REPORT PROVIDED, THE BIOPROSTHETIC VALVE HAS A YELLOW, SOFT AND COMPLIANT TEXTURE. THE NON-FLOW SURFACE OF THE VALVE IS FREE OF ANY THROMBOSES, VEGETATIONS OR CALCIFICATIONS. THE FLOW SURFACE OF THE VALVE REVEALS SEVERAL SUB 1.0MM YELLOW GRANULAR DEPOSITS AND IS FREE OF ANY THROMBOSES OR VEGETATIONS. THERE IS AN AREA OF PANNUS ON THE FLOW SURFACE OF THE VALVE WHICH IS WHITE IN COLOUR AND MEASURES 3.5 X 0.2CM. MICROSCOPIC EXAMINATION SHOWS PERICARDIAL LEAFLET WITH MILD FIBROUS PANNUS. SURFACE RECENT THROMBI IS ALSO NOTED. NO STRUCTURAL DEGENERATION IS NOTED. HOST TISSUE/PANNUS GROWTH 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/ANNULOPLASTY RING. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES/ANNULOPLASTY RINGS IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS. IN THE EARLY POSTOPERATIVE PERIOD, THE HIGHEST INCIDENCE OF PVL HAS BEEN SEEN IN PATIENTS DEVELOPING INFECTIVE ENDOCARDITIS, WHICH IS MOST LIKELY ATTRIBUTED TO INADEQUATE PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS OR NOSOCOMIAL INFECTION. ANNULAR CALCIFICATION IS ALSO A RISK FACTOR FOR THE DEVELOPMENT OF PERI-OPERATIVE PVL AS THE BIOPROSTHESIS MAY NOT SEAT PROPERLY AFTER DEBRIDEMENT. THE OP REPORT INDICATES THAT THERE APPEARED TO BE A LITTLE BIT OF A DEFECT IN THE AREA OF THE RIGHT CORONARY SINUS JUST TO THE RIGHT OF THE COMMISSURE BETWEEN THE LEFT AND RIGHT SINUSES IN THIS CASE. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED WITHOUT THE SAMPLE DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 YEAR AND 3 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK. PER THE OP REPORT, THIS PATIENT PRESENTED (B)(6) 2012 WITH HEART FAILURE. IN (B)(6), ECHO SHOWED A PARAVALVULAR LEAK OF THE AORTIC VALVE. THIS WAS CONFIRMED ON CARDIAC CATHETERIZATION. THE PATIENT'S NATIVE MITRAL VALVE HAD ALSO BECOME CALCIFIED AND STENOTIC; THEREFORE, THE PATIENT WAS REFERRED FOR DUAL VALVE REPLACEMENT SURGERY. UPON INSPECTION OF THE AORTIC VALVE, THERE APPEARED TO BE A LITTLE BIT OF A DEFECT IN THE AREA OF THE RIGHT CORONARY SINUS JUST TO THE RIGHT OF THE COMMISSURE BETWEEN THE LEFT AND RIGHT SINUSES. AFTER REMOVING THE VALVE, IT WAS NOTED THAT THE AREA COULD HAVE POSSIBLY HAD PARAVALVULAR LEAK AND IT DID CORRELATE WITH THE AREA FOUND ON ECHOCARDIOGRAM. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. POST-IMPLANT TEE SHOWED SATISFACTORY REPAIR WITH NO PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R