BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3122395 · Received May 21, 2013

    Report

    Report Number
    2015691-2013-20139
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. THE OP REPORT DOCUMENTS PANNUS INGROWTH ON THE VALVE, WHICH WAS LIKELY THE CAUSE OF THE PATIENT'S STENOSIS AND REGURGITATION. 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. 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. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES 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.

    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 PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO PROSTHETIC AORTIC VALVE STENOSIS AND REGURGITATION SECONDARY TO STRUCTURAL VALVE DETERIORATION. PER THE OP REPORT, THE PATIENT'S AORTA AND ROOT WERE QUITE SMALL. THERE WAS A LARGE AMOUNT OF PANNUS INGROWTH IN THE VALVE. THE STRUTS OF THE VALVE WERE ESSENTIALLY GROWN INTO THE WALL OF THE AORTA. THE PROSTHESIS WAS DIFFICULT TO REMOVE. IN ORDER TO DO SO, THE SURGEON EXCISED THE STRUTS OF THE PROSTHESIS LEAVING THE SEWING RING BEHIND. THE SEWING RING WAS DEBRIDED AS MUCH AS POSSIBLE TO OPTIMIZE THE ORIFICE. THE SURGEON ALSO HAD DIFFICULTY LOCATING THE RIGHT CORONARY ARTERY. THE ANNULUS WAS DEBRIDED FURTHER AND STILL WOULD NOT EVENT FIT A 19 SIZER. THEREFORE, THE AORTOTOMY WAS OPENED DOWN ACROSS THE ANNULUS AND INTO THE ANTERIOR LEAFLET OF THE MITRAL VALVE. THIS WAS THEN RECONSTRUCTED WITH PERICARDIAL PATCH. THIS WAS NOTED TO BE EXTREMELY DIFFICULT GIVEN THE PATIENT'S OBESITY AND SMALL ROOT. THIS ISSUE PROLONGED THE CROSSCLAMP TIME BY AT LEAST AN HOUR. ULTIMATELY, A 19 MM VALVE WAS ABLE TO BE PLACED AND SEATED SATISFACTORILY. AT THIS POINT, THE RIGHT CORONARY ARTERY STILL COULD NOT BE IDENTIFIED. THE AORTOTOMY WAS CLOSED WITH PERICARDIAL PATCH. DUE TO CONCERN OF THE RIGHT CORONARY ARTERY, CORONARY ARTERY BYPASS GRAFTING X1 WITH SAPHENOUS VEIN BYPASS GRAF TO THE DISTAL RIGHT CORONARY ARTERY WAS PERFORMED. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS REASONABLY WELL AND WAS TRANSFERRED TO THE ICU IN SATISFACTORY CONDITION. PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224426 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R