BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3223085 · Received July 12, 2013

    Report

    Report Number
    2015691-2013-20582
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: A COPY OF THE PATIENT'S OP REPORT WAS RECEIVED INDICATING THAT THIS VALVE WAS EXPLANTED DUE TO PERIVALVULAR LEAK (PVL). PREDISCHARGE ECHO SHOWED A WELL-SEATED AORTIC PROSTHESIS WITH NO FISTULAS AFTER IMPLANTATION OF THIS VALVE IN MARCH. HOWEVER, IN FOLLOWUP, THE PATIENT HAD DEVELOPED EVIDENCE OF SIGNIFICANT AORTIC INSUFFICIENCY AROUND THE VALVE WITH FEVERS AND CHILLS, ALTHOUGH HIS CULTURES WERE NEGATIVE. SUBSEQUENT ECHOS REVEALED EVIDENCE OF FISTULIZATION INTO THE RIGHT ATRIUM, THE LEFT ATRIUM, MODERATELY SEVERE TRICUSPID INSUFFICIENCY, AND PROBABLY THE PRESENCE OF THE VENTRICULAR SEPTAL DEFECT AS WELL AS NEW GRANULOMATOUS MATERIAL CONSISTENT WITH VEGETATIONS ON THE MITRAL VALVE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED MULTIPLE FISTULAS AND HE WAS TAKEN BACK FOR REPAIR OF THE FISTULAS AND REDO-AORTIC VALVE REPLACEMENT, WHICH HAD SIGNIFICANT PERIVALVULAR AORTIC INSUFFICIENCY. DURING EXPLANTATION OF THE AORTIC VALVE, THERE WAS NO EVIDENCE OF ENDOCARDITIS ON THE LEAFLETS, BUT THERE WERE 2 AREAS THAT SEEMED TO HAVE DEHISCED LIKELY FROM THE RESIDUAL INFECTION FROM THE TIME OF SURGERY WITH SOME GELATINOUS THIN TISSUE AT THESE SITES. THE DEVICE WAS EXPLANTED AND REPLACE WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. PATIENT WAS SEPARATED FROM CARDIOPULMONARY BYPASS WITH EXCELLENT HEMODYNAMICS. THE NEW AORTIC VALVE LOOKED GOOD ON TEE. THE PATIENT TOLERATED THE PROCEDURE IN SATISFACTORY CONDITION WITH NO REPORTED COMPLICATIONS. REGURGITATION IS CONSIDERED TO BE A PVL IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS. IN THE EARLY POSTOPERATIVE PERIOD, THE HIGHEST INCIDENCE OF PVL HAS BEEN SEEN IN PATIENTS DEVELOPING INFECTIVE ENDOCARDITIS, WHICH IS MOST LIKELY ATTRIBUTED TO INADEQUATE PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS OR NOSOCOMIAL INFECTION. IN THIS CASE, THE OP REPORT DOCUMENTS AREAS THAT DEHISCED LIKELY FROM THE RESIDUAL INFECTION FROM THE TIME OF THE INITIAL SURGERY. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER, IT APPEARS THAT THE PATIENT'S PVL WAS LIKELY RELATED TO HIS PREVIOUS INFECTION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, INSUFFICIENT INFORMATION WAS PROVIDED TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. PER THE PATIENT'S OP REPORT ((B)(6) 2013 SURGERY DATE), THIS VALVE WAS IMPLANTED FOR NATIVE AORTIC VALVE ENDOCARDITIS. THE SUBJECT DEVICE APPEARED TO HAVE EXCELLENT SEATING ON TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE IN SATISFACTORY CONDITION. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED; THEREFORE, THE REASON FOR EXPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322866 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800TFX R-12H2777

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R