BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3388237 · Received October 4, 2013

    Report

    Report Number
    2015691-2013-21217
    Event Type
    Death
    Date Received
    October 4, 2013
    Date of Event
    January 4, 2012
    Report Date
    September 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NO. = 3000TFX OR 3300TFX (NOT SPECIFIED IN ARTICLE). PMA/510(K) #: P860057/S022 AND P860057/S042. METHOD: # DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: ARTICLE: PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2012; DOI:10.1016/J.JTCVS.2012.01.024 "TEN-YEAR COMPARISON OF PERICARDIAL TISSUE VALVES VERSUS MECHANICAL PROSTHESES FOR AORTIC VALVE REPLACEMENT IN PATIENTS YOUNGER THAN 60 YEARS OF AGE". ABSTRACT: OBJECTIVE: AORTIC VALVE REPLACEMENT USING A TISSUE VALVE IS CONTROVERSIAL FOR PATIENTS YOUNGER THAN 60 YEARS OLD. THE LONG-TERM SURVIVAL IN THIS AGE GROUP, THE EXPECTED EVENT RATES DURING LONG-TERM FOLLOW-UP, AND VALVE-RELATED COMPLICATIONS ARE NOT CLEARLY DETERMINED. METHODS: FROM JANUARY 2000 TO DECEMBER 2009, OVERALL SURVIVAL, VALVE-RELATED EVENTS, AND ECHOCARDIOGRAPHIC OUTCOMES WERE ANALYZED IN ALL PATIENTS YOUNGER THAN 60 YEARS OF AGE, WHO UNDERWENT BIOLOGIC AORTIC VALVE REPLACEMENT. PATIENTS WHO RECEIVED A PERIMOUNT CARPENTIER-EDWARDS PERICARDIAL TISSUE VALVE (N = 103) WERE SELECTED AND COMPARED WITH A PROPENSITY MATCHED GROUP OF 103 PATIENTS WHO RECEIVED AORTIC VALVE REPLACEMENT USING A MECHANICAL BILEAFLET VALVE. THE MEAN FOLLOW-UP WAS 33 PLUS/MINUS 24 MONTHS (RANGE, 2¿120), AND THE MEAN AGE AT IMPLANTATION WAS 50.6 PLUS/MINUS 8.8 YEARS (BIOPROSTHESIS, 55 PLUS/MINUS 8.9 YEARS; MECHANICAL VALVE, 50 PLUS/MINUS 8.6 YEARS; P = .03). RESULTS: SURVIVAL WAS SIGNIFICANTLY REDUCED IN PATIENTS AFTER BIOLOGIC AORTIC VALVE REPLACEMENT (90.3 PERCENT VS 98 PERCENT; P = .038). FREEDOM FROM ALL VALVE-RELATED COMPLICATIONS (BIOPROSTHESIS, 54.5 PRTVRNY; MECHANICAL VALVE, 51.6 PERCENT; P = NS) AND FREEDOM FROM REOPERATION (BIOPROSTHESES, 100 PERCENT; MECHANICAL VALVE, 98 PERCENT; P = NS) WERE COMPARABLE IN BOTH GROUPS. THE AVERAGE TRANSVALVULAR MEAN (11.2 PLUS/MINUS 4.2 MM HG VS 10.5 PLUS/MINUS 6.0 MM HG, P = .05) AND PEAK (19.9 PLUS/MINUS 6.7 MM HG VS 16.7 PLUS/MINUS 8.0 MM HG, P = .03) GRADIENTS WERE GREATER AFTER BIOLOGIC AORTIC VALVE REPLACEMENT. REGRESSION OF THE LEFT VENTRICULAR MASS INDEX WAS MORE PRONOUNCED AFTER MECHANICAL VALVE REPLACEMENT (118.5 PLUS/MINUS 24.9 G/M2 VS 126.5 PLUS/MINUS 38.5 G/M2; P = NS). THE ECHOCARDIOGRAPHIC PATIENT¿PROSTHESIS MISMATCH WAS GREATER AT FOLLOW-UP AFTER BIOLOGICAL AORTIC VALVE REPLACEMENT (0.876 PLUS/MINUS 0.2 CM2/M2 VS 1.11 PLUS/MINUS 0.4 CM2/M2; P = .01). ORAL ANTICOAGULATION WAS A PROTECTIVE FACTOR FOR SURVIVAL AMONG THE BIOPROSTHETIC VALVE PATIENTS (P = .024). CONCLUSIONS: IN THE PRESENT LIMITED COHORT OF PATIENTS YOUNGER THAN 60 YEARS OLD, BIOLOGIC AORTIC VALVE REPLACEMENT WAS ASSOCIATED WITH REDUCED MID-TERM SURVIVAL COMPARED WITH SURVIVAL AFTER MECHANICAL AORTIC VALVE REPLACEMENT. DESPITE SIMILAR VALVE-RELATED EVENT RATES IN BOTH GROUPS, THE BETTER HEMODYNAMIC PERFORMANCE OF THE MECHANICAL VALVES AND/OR PROTECTIVE EFFECT OF ORAL ANTICOAGULATION SEEMED TO IMPROVE THE OUTCOME. THE TRANSCATHETER VALVE-IN-VALVE INTERVENTION AS POTENTIAL TREATMENT OF TISSUE VALVE DEGENERATION SHOULD NOT BE CONSIDERED THE SOLE BAILOUT STRATEGY FOR YOUNGER PATIENTS BECAUSE NO EVIDENCE IS AVAILABLE THAT THIS WOULD IMPROVE THE OUTCOME.

    Description of Event or Problem · 1

    PATIENT AND EVENT SPECIFICS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502685 CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R