BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1961948 · Received January 15, 2011

    Report

    Report Number
    2015691-2011-14688
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    September 27, 2010
    Report Date
    December 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SURGEON, THE REASON FOR VALVE EXPLANT DURING THE SURGICAL PROCEDURE WAS NOT RELATED TO DEVICE MALFUNCTION. THE EXPLANT AT THE TIME OF IMPLANT WAS A RESULT OF PATIENT AND PROCEDURAL FACTORS.

    Additional Manufacturer Narrative · 1

    (B)(4) = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THIS PATIENT ALSO HAD ANOTHER EDWARDS VALVE EXPLANTED. PLEASE REFERENCE THE OTHER MEDWATCH SUBMITTED UNDER (B)(6). 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

    PER OPERATIVE REPORT RECEIVED: PATIENT WAS DIAGNOSED WITH SEVERE AORTIC STENOSIS, HYPERTENSION, AND OSTEOARTHRITIS. SUMMARY OF PROCEDURE IS AS FOLLOWS: AORTIC ROOT REPLACEMENT AND AORTIC VALVE REPLACEMENT WITH A 3-MM MEDTRONIC STENTLESS FREESTYLE BIOPROSTHESIS; CORONARY REIMPLANTATION, AORTIC VALVE REPLACEMENT WITH A 23 AND 25 CARPENTIER MAGNA BIOPROSTHESIS; REMOVAL OF BIOPROSTHESIS; AORTIC ANNULUS RECONSTRUCTION; INSERTION OF ATRIOVENTRICULAR PACING WIRES; INSERTION OF A RIGHT SUBCLAVIAN TRIPLE-LUMEN CENTRAL LINE. DETAILS OF PROCEDURE: (B)(6) MALE WHO HAS LONG-STANDING AORTIC STENOSIS THAT HAS PROGRESSED TO CRITICAL STAGE WITH A VALVE AREA OF LESS THAN 1.8 SQUARE CM AND A GRADIENT ABOVE 85 MMHG AND FOR THIS REASON, AORTIC VALVE REPLACEMENT HAS BEEN INDICATED. ... A TRANVERSE AORTOTOMY WAS PERFORMED WITH ADEQUATE EXPOSURE OF THE AORTIC VALVE, WHICH WAS FOUND TO BE HEAVILY CALCIFIC WITH VERY RIGID LEAFLETS. THE LEAFLETS WERE RESECTED. THERE WAS ALSO SEVERE CALCIFICATION AT THE LEVEL OF THE ANNULUS. DECALCIFICATION OF THE ANNULUS WAS PERFORMED UNTIL AN ADEQUATE SEWING RING WAS OBTAINED. WE SIZED THE VALVE TO A 25-MM CARPENTIER MAGNA BIOPROSTHESIS. THE PATIENT WAS SUBSEQUENTLY WEANED OFF CARDIOPULMONARY BYPASS. HOWEVER, TRANSESOPHAGEAL ECHOCARDIOGRAPHY INITIALLY HAD DEMONSTRATED ADEQUATE FUNCTION OF THE VALVE AND NOW SHOWED THE EVIDENCE OF WHAT SEEMED TO BE A PERIVALVULAR LEAK TOWARDS THE NONCORONARY SINUS JUNCTION WITH THE RIGHT CORONARY SINUS, WHICH SEEMS TO BE QUITE SIGNIFICANT AND HAS INCREASED IN SIZE. FOR THIS REASON, WE DECIDED TO REPAIR THE SAME IF POSSIBLE WITH PLEDGETED SUTURES. WE APPLIED TWO 2-0 ETHIBOND PLEDGETED SUTURES THAT SEEMED TO CONTROL PROPERLY THE LEAKING PORTION OF THE VALVE AT THIS POSITION. INTERROGATION OF THE VALVE DEMONSTRATED REPAIR OF THE PERIVALVULAR LEAK AT THE LEVEL OF THE JUNCTION OF THE NONCORONARY AND RIGHT CORONARY SINUS. HOWEVER, THERE WAS LEAKING TOWARDS THE RIGHT CORONARY SINUS IN THE ANTERIOR AND MID PORTION. BASED ON THESE FINDINGS AND WITH SIGNIFICANT PERIVALVULAR LEAK IN 2 DIFFERENT LOCATIONS, WE PRESUMED THAT THERE WAS SOME DISRUPTION OF THE SUTURE LINE AT THE LEVEL OF THE AORTIC ANNULUS. WE DECIDED TO RE-EXPLORE AND FULLY ATTACH THE VALVE WITH PLEDGETED SUTURES. WE IMMEDIATELY OPENED THE AORTOTOMY AND WE WERE ABLE TO EXPLANT TO THE CARPENTIER MAGNA 25-MM PROSTHESIS WITHOUT DIFFICULTY, RECOVERING ALL THE SUTURES AND ALL THE PLEDGETS WITHOUT DIFFICULTY. THERE ANNULUS SEEMED TO BE VERY FRAIL TOWARDS THE LEVEL OF THE RIGHT CORONARY AND NONCORONARY SINUS. FOR THIS REASON, WE USED 2 PLEDGETED STITCHES OF 2-0 ETHIBOND AND SIZED TO A 23-MM CARPENTIER MAGNA BIOPROSTHESIS. ONCE THE CARPENTIER MAGNA PROSTHESIS WAS SUTURED IN PLACE, THE SUTURES WERE TIED AND THE AORTOTOMY WAS CLOSED. ONCE THE AORTOTOMY WAS CLOSED AND THE CROSSCLAMP WAS RELEASED, THE PATIENT WAS DE-AIRED IN THE SAME FASHION WITH ACTIVE SUMP FROM THE ASCENDING AORTA. WE ENCOUNTERED NOW THE PRESENCE OF A LARGE COMMUNICATION THAT SEEMED TO BE BETWEEN THE AORTIC ANNULUS AND TOWARDS THE RIGHT CAVITY WITH A CONSTANT FLOW THAT WAS SUGGESTIVE OF THE POSSIBILITY OF A VSD AT THIS LEVEL. ALTHOUGH NO EVIDENCE OF PERIVALVULAR LEAK, THIS SEEMED TO BEHAVE LIKE A CONSTANT FLOW THAT MAY BE SIGNIFICANT AORTIC INSUFFICIENCY. THE VALVE ITSELF SEEMED TO BE WORKING PROPERLY, BUT THERE WAS A LARGE DISRUPTION OF THE ANNULUS. AT THIS POINT, WE OBSERVED ALSO AN ACTIVE BLEEDING EXTERNALLY FROM THE ANNULUS. WITH THE PRESENCE OF AN ANNULUS DISRUPTION AND A FAILED VALVE REPLACEMENT WITH A BIOLOGICAL PROSTHESIS WHEN THE STENT WAS FASHIONED, WE ESTIMATED THAT THE PATIENT WOULD REQUIRE AN AORTIC ROOT REPLACEMENT WITH A FREESTYLE STENTLESS BIOPROSTHESIS. AT THIS POINT IN THE PROCEDURE, WE DECIDED TO EXTEND THE SEPTOSTOMY TO A FULL LINE STERNOTOMY.

    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 DEVICE WAS EXPLANTED AT THE TIME OF IMPLANT. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A RESPONSE WAS RECEIVED. PER THE SURGEON, CALCIFICATION, DEHISCENCE, AND PARAVALVULAR LEAK ARE ALL CONDITIONS THAT APPLY TO THE EDWARDS DEVICE. IT WAS ALSO NOTED THAT THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A DEVICE MALFUNCTION; HOWEVER, THE REASON WAS PATIENT/PROCEDURE RELATED. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-10E1115

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention