BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2012521 · Received March 10, 2011

    Report

    Report Number
    2015691-2011-14984
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. PER THE DISCHARGE SUMMARY RECEIVED ON 02/28/2011, IT WAS LEARNED THAT THE PATIENT DIET ON (B)(6) 2011. POST-OP, ON ECMO AND CVVHD HAD DRAMATIC IMPROVEMENT OVER 1ST 48 HOURS SUCH THAT A WINDOW OF OPPORTUNITY SEEMED TO PRESENT ITSELF FOR SEPARATION FROM ECMO. THIS WAS DONE ON SUNDAY. HE WAS FOUND TO BE PROFOUNDLY DEPENDENT ON EPI AT THAT TIME, AND WE DECIDED TO START IV SOLUMEDROL AND VASOPRESSIN. BY MONDAY, HE WAS NOT APPEARING TO NEED THE IABP MUCH. HE WAS NOW BECOMING MORE THROMBOCYTOPENIC. THEREFORE, THIS WAS REMOVED MONDAY AFTERNOON. BY TUESDAY, HE WAS STABLE, AND BECAUSE OF CONCERNS OF INFECTION, WE DECIDED TO CLOSE THE CHEST IN THE OR. THIS INITIALLY WENT VERY WELL, WITH EASY APPOSITION OF THE STERNA EDGES. UPON ARRIVAL IN ICU, HE WAS UNSTABLE WITH SUDDEN DROP IN SVO2 AND APPEARANCE OF TAMPONADE. THE CHEST TUBES WERE NOT ON SUCTION, AND AS SOON AS THEY WERE ATTACHED, THE SVO2 CLIMBED BACK UP¿ OVER THE NEXT 24-48 HOURS HE REMAINED STABLE BUT NOT IMPROVING, WITH VARYING NEED FOR LEVO (UP TO 30 AT TIMES). THE MAIN ISSUE BECAME THROMBOCYTOPENIA, REQUIRING MULTIPLE TRANSFUSIONS OF PLATELETS, AS WELL AS OTHER BLOOD PRODUCTS. ON WEDNESDAY, HIS CK LEVEL WAS FOUND TO BE 37,000 WITH NO IDENTIFIABLE SOURCE. A DECISION WAS MADE TO CT SCAN HIS WHOLE BODY TO TRY AND IDENTIFY THE SOURCE, BUT WHEN HIS CHEST TUBES WERE SEPARATED FROM SUCTION, HE AGAIN BECAME UNSTABLE. [SURGEON] WAS ABLE TO OPEN THE CHEST IN THE ICU, BUT THERE WAS NO IMPROVEMENT. AT THIS POINT, IT WAS OUR FEELING THAT THE LIKELIHOOD OF RECOVERY WAS VERY, VERY LOW. BY THURSDAY A.M., HIS CK WAS > 60K, DESPITE STOPPING PROPOFOL. HE WAS STILL THROMBOCYTOPENIC, AND APPEARED TO BE IN PROFOUND RIGHT HEART FAILURE. DECIDED TO TRY INHALED NITRIC OXIDE FOR 24 HOURS TO SEE IF THERE WAS ANY CHANCE OF IMPROVEMENT. UNFORTUNATELY, HE CONTINUED TO DETERIORATE, AND BY FRIDAY MORNING, IT WAS CLEAR THAT THERE WOULD BE NO RECOVERY.

    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, THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS. PER CLINICAL NOTE AND OPERATIVE FINDINGS: ECHO AND CT SHOWED RECURRENT PRESUMED ENDOCARDITIS INVOLVING THE AORTIC ANNULUS AND ROOT, WITH SEVER AI, ACTUALLY ON CT THE DEFECT APPEARED TO BE ONE INVOLVING A PSEUDOANEURYSM OF THE SINUSES OF VALSALVA AND A FISTULA FROM OUTSIDE THE AORTA DOWN TO THE LV...AORTIC HOMOGRAFT HAD A HOLE IN THE LEFT CORONARY SINUS, WITH FREE PASSAGE OF BLOOD OUTSIDE OF THE ROOT AND THEN INTO A LARGE ABSCESS CAVITY INVOLVING AT LEAST 75% OF THE CIRCUMFERENCE OF THE AORTIC ANNULUS. AT ITS BASE, THERE WAS A SORT OF NEO-ANNULUS (BELOW THE LEVEL OF THE HOMOGRAFT). AS MUCH OF THE OLD HOMOGRAFT TISSUE AS POSSIBLE WAS RESECTED. MUCH OF THE ROOT TISSUE NEAR THE ANNULUS WAS NECROTIC AND APPEARED INFECTED. THERE WAS A DEFECT BETWEEN THE ANTERIOR MITRAL LEAFLET AND THE MITRAL ANTERIOR ANNULUS AFTER THE DEBRIDEMENT WAS COMPLETED. THIS WAS CLOSED WITH THE MITRAL REPLACEMENT SUTURES, AND COVERED WITH THE MITRAL ANTERIOR LEAFLET TISSUE FROM THE HOMOGRAFT. INITIALLY SLOW TO COME OFF CPB (VERY LONG INITIAL XC AND CPB TIME OF ALMOST 9 AND 11 HOURS, RESPECTIVELY). HOWEVER, ABLE TO COME OFF WITH NO AORTIC INSUFFICIENCY, NO PERIVALVULAR MITRAL LEAK, AND LOW MITRAL MEAN GRADIENT. PROTAMINE ADMINISTERED SLOWLY AND INITIALLY FINE, AND THE FIELD WAS SURPRISINGLY VERY DRY. HOWEVER, ABOUT 10 MINUTES AFTER INFUSION COMPLETED, AND AS WE WERE DISSECTING OUT THE OMENTUM TO COVER THE AORTA, THE PATIENT'S BLOOD PRESSURE DROPPED TO ABOUT 60 SYSTOLIC, THE RIGHT VENTRICLE BECAME DILATED AND DYSKINETIC, AND THERE WAS PROFUSE PULMONARY EDEMA COMING FROM THE ENDOTRACHEAL TUBE. THE PRESUMED DIAGNOSIS WAS A SEVERE PROTAMINE REACTION. THEREFORE, HE WAS RE-HEPARINIZED AND PUT BACK ON CPB. ULTRAFILTRATION WAS INITIATED FOR ABOUT 1 HOUR AND 2 LITERS WERE REMOVED. HE DID NOT WEAN FROM CPB DESPITE AN IABP.

    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 08D081

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H| R