BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2964072 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19295
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL; THEREFORE, EDWARDS COULD NOT ASSESS THE VALVE FOR THE SOURCE OF THE REPORTED CALCIFICATION. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS AND INSUFFICIENCY WAS MOST LIKELY CAUSED BY THE HEAVY CALCIFICATION NOTED ON THE DEVICE. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    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 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS, 7 MONTHS DUE TO PULMONARY STENOSIS AND INSUFFICIENCY WITH CALCIFICATION. ACCORDING TO THE OP REPORT, THIS IS A (B)(6) BOY BORN WITH TETRALOGY OF FALLOT. HE UNDERWENT A 4MM RIGHT MODIFIED BLALOCK-TAUSSIG SHUNT ON (B)(6) 1998. HE THEN UNDERWENT COMPLETE REPAIR OF TETRALOGY OF FALLOT WITH A TRANSANNULAR PATCH ON (B)(6) 1999. ON (B)(6) 2003, HE HAD INSERTION OF A 21 MM BOVINE PERICARDIAL VALVE (SUBJECT DEVICE) WITH HOMOGRAFT PATCHING OF THE RIGHT PULMONARY ARTERY AND THE RV OUTFLOW TRACT. HE NOW HAD SIGNIFICANT PULMONARY VALVE STENOSIS AND SEVERE PULMONARY VALVE INSUFFICIENCY. DURING EXPLANTATION OF THE PROSTHETIC VALVE, IT WAS NOTED THAT THE ORIFICE OF THE VALVE WAS HEAVILY CALCIFIED AND ADMITTED A 12 MM DILATOR. THERE WAS A 2 MM PATENT FORAMEN OVALE. THE HOMOGRAFT WAS HEAVILY CALCIFIED AND REQUIRED EXCISION. THE DEVICE WAS REPLACED WITH A CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT. THE POSTOPERATIVE ECHOCARDIOGRAM SHOWED NO RESIDUAL PULMONARY STENOSIS OR PULMONARY INSUFFICIENCY, WITH GOOD BIVENTRICULAR FUNCTION. THERE WAS MILD CENTRAL AORTIC VALVE INSUFFICIENCY, UNCHANGED FROM PREOP. THERE WAS ALSO MILD TRICUSPID INSUFFICIENCY THAT WAS ALSO UNCHANGED FROM PREOP. THERE WAS NO ATRIAL LEVEL SHUNTING. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE CARDIAC CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66212 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R