BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 2080715 · Received May 6, 2011

    Report

    Report Number
    2015691-2011-15468
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    January 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AN ANNULOPLASTY RING AND REPLACE WITH A BIOPROSTHETIC VALVE, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, OR PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. IN THIS CASE, IN THE RESPONSE RECEIVED FROM THE SURGEON ON (B)(6) 2011, IT WAS LEARNED THAT THE ANNULOPLASTY RING WAS EXPLANTED DUE TO ENDOCARDITIS THAT HAD AFFECTED THE NATIVE VALVE AND NOT DUE TO A DEVICE MALFUNCTION. THIS DEVICE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE HOSPITAL AND NO EVALUATION OF THE DEVICE CAN BE DONE. THE PATIENT WAS SATISFACTORILY IMPLANTED WITH A 6900P VALVE AS THE REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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, AN ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH 17 DAYS (1.57 MONTHS) AND REPLACED BY AN EDWARDS BIOPROSTHETIC VALVE. THE EXPLANT WAS DUE TO ENDOCARDITIS WHICH HAD AFFECTED THE NATIVE VALVE. THE SURGEON INDICATED THIS EXPLANT WAS NOT DEVICE RELATED. THE SURGEON'S RESPONSE ALSO INDICATED THE SOURCE OF THE ENDOCARDITIS WAS FROM A STERNAL INFECTION. THE OPERATIVE REPORT INDICATIONS FOR SURGERY PROVIDE THE FOLLOWING: THIS IS A (B)(6) YEAR-OLD GENTLEMAN WHO HAD PREVIOUS MITRAL VALVE REPAIR IN NOVEMBER BY [SURGEON]. HE HAS DONE WELL AND WAS DISCHARGED HOME. HOWEVER, HE RETURNED ABOUT TWO WEEKS LATER WITH FEVER AND SEPSIS AND WAS FOUND TO HAVE BACTERIAL ENDOCARDITIS OF THE MITRAL VALVE. DURING THE INITIAL ATTEMPT TO REDO THE OPERATION, [SURGEON] FOUND THERE WAS A LARGE AMOUNT OF PURULENT MATERIAL IN HIS MEDIASTINUM FROM LIKELY MEDIASTINITIS AND THEREFORE, HE ABANDONED THE SURGERY AND TREATED THE PATIENT WITH IV ANTIBIOTICS. THE PATIENT CONTINUED TO DO POORLY WITH ON AND OFF HEART FAILURE, SEPSIS, RENAL DYSFUNCTION. THEREFORE, I WAS ASKED TO PERFORM THE REDO SURGERY VIA A RIGHT THORACOTOMY BECAUSE OF THE MEDIASTINITIS. THE MEDIASTINITIS BY NOW HAS BEEN RESOLVED AND THE STERNUM WAS STABLE. THE OPERATIVE REPORT PROVIDED THE FOLLOWING: THE MITRAL VALVE WAS INSPECTED. THERE IS A SIGNIFICANT AREA OF INFECTION AND INFLAMMATION AROUND THE POSTERIOR MEDIAL COMMISSURE OF THE MITRAL VALVE WITH PERFORATION OF THE POSTERIOR LEAFLET AROUND P3 WITH INDURATION IN THE ANNULUS AROUND THE AREA. THE ANTERIOR LEAFLET WAS FREE OF ANY SIGNIFICANT VEGETATION. THE ANTERIOR AND POSTERIOR LEAFLETS WERE THEN EXCISED. THE PREVIOUS REPAIR ANNULOPLASTY BAND WAS EXCISED AND SENT TO MICROBIOLOGY. THE PLEDGETS FROM PREVIOUS REPAIR WERE REMOVED. THE POSTERIOR LEAFLETS WERE ALSO REMOVED. I DID NOT PRESERVE ANY POSTERIOR LEAFLET BECAUSE OF THE PRESENCE OF INFLAMMATION AND PRESENCE OF INFECTION. HOWEVER, THE ANNULUS OF TISSUE WAS QUITE FRIABLE AND THEREFORE, I DECIDED TO USE 2-0 TICRON HORIZONTAL MATTRESS SUTURES WITH PLEDGETS. PLEDGETS WERE KEPT ON THE ATRIAL SIDE. A TOTAL OF 16 SUTURES WERE USED. A 31 MM EDWARDS-PERIMOUNT MITRAL PROSTHESIS WAS SELECTED. THE VALVE SEATED VERY EASILY AND ALL SUTURES WERE LEGATED. INSPECTION SHOWED INTACT SUTURE LINE ALL AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 08F141

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R