BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 3544677 · Received December 31, 2013

    Report

    Report Number
    2015691-2013-21989
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P010041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO INFORMATION AVAILABLE REGARDING PATIENTS IN STUDY. NO INFORMATION AVAILABLE FOR SERIAL NUMBERS OF DEVICES IN STUDY. ARTICLE IS ATTACHED. UNFORTUNATELY, AUTHORS ARE NO LONGER AVAILABLE FOR COMMENT AT THIS HOSPITAL. CONCLUSION: PER THE ARTICLE, "BASED ON OUR CLINICAL EXPERIENCE, WE SUGGEST THAT LONG-TERM DURABILITY OF PULMONARY-SITE SECOND-GENERATION PORCINE AORTIC BIOPROSTHESIS IS PROMISING IN YOUNG ADULT PATIENTS, BUT THAT THE PRESSURE LOAD CAUSED BY PULMONARY HYPERTENSION OR DISTAL PULMONARY OBSTRUCTION MAY BE A RISK FACTOR LIMITING THE DURABILITY OF THE VALVE." DESPITE ATTEMPTS TO REACH THE AUTHORS, NO RESPONSE HAS BEEN RECEIVED AND NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THROUGH AN ARTICLE PUBLISHED 07 JULY 2011 IN THE JAPANESE SOCIETY FOR ARTIFICIAL ORGANS 2011: J ARTIF ORGANS (2011) 14:289¿293 DOI 10.1007/S10047-011-0582-8, "INFLUENCE OF PRESSURE LOAD ON DURABILITY OF PULMONIC XENOBIOPROSTHESIS IN YOUNG ADULTS". ABSTRACT: THE AIM OF THIS STUDY WAS TO INVESTIGATE THE EFFECTS OF PRESSURE LOAD (PULMONARY ARTERIAL PRESSURE) ON THE LONG-TERM DURABILITY OF SECOND-GENERATION XENOBIOPROSTHESES IN THE PULMONARY POSITION IN YOUNG ADULTS. THIRTEEN PATIENTS SURVIVED PULMONARY VALVE REPLACEMENT FOR PULMONARY REGURGITATION USING THE SECOND-GENERATION AORTIC PORCINE BIOPROSTHESIS AT [HOSPITAL NAME REDACTED] BETWEEN 1985 AND 2009. THE MEAN AGE AT PULMONARY VALVE REPLACEMENT WAS 40.5 YEARS, AND THE MEAN PROSTHETIC VALVE SIZE WAS 25.3 MM. TWO PATIENTS DEVELOPED STRUCTURAL VALVE DETERIORATION 6 AND 9 YEARS, RESPECTIVELY, AFTER PULMONARY VALVE REPLACEMENT. BOTH PROSTHETIC VALVES WITH STRUCTURAL VALVE DETERIORATION WERE SUBJECTED TO LONG-TERM HIGH LEVELS OF PRESSURE LOAD. NO VALVE STRUCTURAL FAILURE WAS OBSERVED IN THE REMAINING 11 PATIENTS WHO EXPERIENCE LOW-PRESSURE LOAD DURING A MEAN FOLLOW-UP PERIOD OF 11.9 YEARS. THE FREEDOM FROM STRUCTURAL VALVE DETERIORATION AT 15 YEARS WAS 75.8% FOR THE OVERALL POPULATION, BUT 100% FOR THOSE WITH LOW-PRESSURE LOAD. OUR FINDINGS SUGGEST THAT THE LONG-TERM DURABILITY OF PULMONARY-SITE BIOPROSTHETIC VALVES IN YOUNG ADULT PATIENTS IS PROMISING BUT THAT PRESSURE LOAD MIGHT BE A RISK OF THE LIMITED DURABILITY OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681602 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R