BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2030008 · Received March 25, 2011

    Report

    Report Number
    2015691-2011-15094
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THROUGH FURTHER FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE PATIENT EXPIRED FROM STROKE. ACCORDING TO THE SURGEON, THE EDWARDS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. IT HAS BEEN DETERMINED THAT THIS EVENT IS NOT REPORTABLE; THIS REPORT WAS SUBMITTED IN ERROR.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. ALSO, DUE TO PATIENT PRIVACY REGULATIONS, INFORMATION REGARDING THE CAUSE OF DEATH COULD NOT BE OBTAINED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    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 PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 MONTH. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE PATIENT'S OPERATIVE REPORT AND DISCHARGE SUMMARY WERE RECEIVED. ACCORDING TO THE REPORTS, THE PATIENT PRESENTED WITH AORTIC VALVE ENDOCARDITIS WITH SEVERE AORTIC INSUFFICIENCY STATUS POST AORTIC VALVE REPLACEMENT IN (B)(6) OF 2010. THEREFORE, THE PATIENT HAD A SECOND AORTIC VALVE REPLACEMENT USING AN 25 MM CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS. POST-IMPLANT ECHO SHOWED THE VALVE WELL-SEATED WITH NO EVIDENCE OF PERIVALVULAR REGURGITATION AND WITH ACCEPTABLE LEAFLET MOBILITY. THE PATIENT TOLERATED THE PROCEDURE WELL. HIS POSTOPERATIVE COURSE WAS SOMEWHAT PROLONGED AS PREDICTED, BASED UPON HIS COMORBIDITIES, SPECIFICALLY HIS OBSTRUCTIVE SLEEP APNEA AND HIS SIGNIFICANT VOLUME OVERLOAD FROM HIS ACUTE ON CHRONIC HEART FAILURE. HE DID HAVE SEVERAL ECHOCARDIOGRAMS PERFORMED DURING HIS POSTOPERATIVE COURSE SYSTEM MONITOR HIS PROGRESS AND WHILE THERE WAS SOME SUGGESTION OF A PERICARDIAL EFFUSION, THE NATURE OF HIS DISSECTION WAS LIMITED TO THE RIGHT SIDE OF HIS HEART AND HIS ASCENDING AORTA UP AND THAT MAY BE JUST RESIDUAL SCARRING AND ADHESION FROM HIS MEDIASTINAL FAT AND PREVIOUS OPERATION. IN ADDITION, THERE WAS SOME SUGGESTION OF AORTIC INSUFFICIENCY WITH HIS NEW VALVE, BUT ON CLOSER INSPECTION THERE WAS NO OBVIOUS PARAVALVULAR REGURGITATION AND IT APPEARED TO BE PREDOMINANTLY A WIDE CENTRAL LOW VELOCITY JET THAT DID NOT EXTEND INTO HIS LV. ONCE THE PATIENT WAS STABILIZED ON ALL OF HIS MEDICATIONS AND GOT A DEFINITIVE COURSE OF THERAPY FOR HIS PRESUMED ENDOCARDITIS, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. OF NOTE, THE SURGEON WAS QUITE PLEASED WITH THE PATIENT'S POSTOPERATIVE COURSE, DESPITE HIS MULTIPLE CHALLENGES. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death