BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3811347 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01137
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: REPORT OF AN AORTIC BIOPROSTHETIC VALVE EXPLANT AFTER ONE (1) YEAR. DESPITE MULTIPLE ATTEMPTS BY EDWARDS WITH THE HEALTHCARE PROVIDER, THE REASON FOR EXPLANT WAS NOT PROVIDED AND THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE AND MECHANISM LEADING TO THIS EXPLANT CANNOT BE IDENTIFIED OR EVALUATED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE. IT MAY OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE AT THE ANNULUS. IN THIS CASE, ADDITIONAL INFORMATION FROM THE SURGEON INDICATES THAT THIS EXPLANT WAS DUE TO PERIVALVULAR LEAK RELATED TO THE PATIENT'S FRIABLE TISSUE AT THE ORIGINAL IMPLANT AND PREVIOUS ENDOCARDITIS. THE SURGEON INDICATES NO DEVICE MALFUNCTION RELATED TO THIS EVENT. THE DEVICE SHOWED NO VEGETATIONS OR CALCIFICATION AT EXPLANT. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    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. IN THIS CASE, IT WAS REPORTED THAT THE SUBJECT EDWARDS BIOPROSTHETIC AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY ONE (1) YEAR AND REPLACED WITH ANOTHER EDWARDS SAME MODEL/SIZE VALVE.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER PROVIDED EVENT AND PATIENT MEDICAL RECORDS; IT WAS LEARNED THAT THIS IS A (B)(6) YEAR OLD GENTLEMAN THAT HAD PRESENTED WITH NATIVE VALVE ENDOCADITIS ONE (1) YEAR AGO AND UNDERWENT AN IMPLANT OF AN EDWARDS AORTIC BIOPROSTHETIC VALVE (SUBJECT DEVICE). AT THE TIME OF IMPLANT, THE VALVE FUNCTIONED NORMALLY WITH NO PERIVALVULAR LEAKS, BUT THE PATIENT WAS NOTED TO HAVE A SOMEWHAT FRIABLE SEPTUM ASSOCIATED WITH A SMALL ABSCESS THE PATIENT NOW, ONE (1) YEAR POST IMPLANT, WAS FOUND TO HAVE SEVERE PARAVALVULAR LEAK, ALONG THE BASE OF THE RIGHT CORONARY SINUS, WHICH IN ASSOCIATION WITH THE AREA OF SOMEWHAT SOFT AND FRIABLE MUSCULAR SEPTUM AT THE TIME OF THE ORIGINAL SURGERY. THE PATIENT THEN UNDERWENT A REDO STERNOTOMY, WHERE COMPLETE DEHISCENCE OF THE BIOPROSTHETIC VALVE WAS SEEN ALONG THE BASE OF THE RIGHT CORONARY SINUS. ANOTHER BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED WITH NO NOTED COMPLICATIONS, AND THE PATIENT WAS TRANSFERRED BACK TO THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290397 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R