BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2212541 · Received August 16, 2011

    Report

    Report Number
    2015691-2011-16046
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ON (B)(6) 2011 - RESEARCH AND DEVELOPMENT COMPLETED THE FUNCTIONAL TEST AND CONCLUDED WITH THE FOLLOWING: "THIS VALVE WAS REPORTEDLY EXPLANTED AT IMPLANT DUE TO CENTRAL AORTIC REGURGITATION. NO ECHOCARDIOGRAPHY WAS PROVIDED, THUS THE BEHAVIOR OF THE VALVE AND THE REGURGITATION OBSERVED IN VIVO COULD NOT BE CONFIRMED. EDWARDS' STANDARDIZED IN VITRO TESTING DEMONSTRATES THAT THE REGURGITATION OF THE VALVE IS ACCEPTABLE PER (B)(6). THE AS-RECEIVED VALVE SHOWED A 2.2% TOTAL REGURGITANT FRACTION (TRF), WITH NO CENTRAL LEAKAGE PATH PRESENT. THIS VALUE IS MORE THAN FOUR TIMES LOWER THAN 10% ALLOWANCE PER (B)(4) FOR THIS SIZE OF VALVE." THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED REGURGITATION. HOWEVER, THE OPERATIVE REPORT INDICATED THE AORTIC RING WAS DECALCIFIED AND THERE WAS SEVERE SUB-AORTIC STENOSIS WHICH WAS ALSO EXCISED. THE AORTIC ROOT WAS REPLACED AND THE TISSUE WAS REFERRED TO AS FRAGILE. THESE FACTORS MOST LIKELY ARE THE CAUSE FOR THE CENTRAL AORTIC REGURGITATION. CORRECTED DATA: THE DHR REVIEW WAS COMPLETED AND THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. A PRELIMINARY EXAMINATION WAS DONE BY RECEIVING IN (B)(6). "THE DEVICE LOOKS RELATIVELY NEW AND IN PRETTY GOOD CONDITION AND NO CALCIFICATION IS VISIBLE. THE LEAFLETS ARE EASY TO MOVE AND DO NOT INDICATE CALCIFICATION OR ANY OTHER MALFUNCTION JUST FROM OUR SHORT PRELIMINARY EVALUATION FROM TODAY. IT IS NOT OBVIOUS FOR US, WHY THIS PRODUCT WAS RETURNED AS A COMPLAINT." THE DEVICE WAS FORWARDED TO OUR PRODUCT EVALUATION LABORATORY IN IRVINE FOR FULL EVALUATION. EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITS SERRATED MARKINGS NOTED IN THE TISSUE, MOST LIKELY DUE TO AN IMPRESSION OF A SURGICAL TOOL AT EXPLANT. NO OTHER INCONSISTENCIES WERE DETECTED AS LEAFLETS ARE INTACT AND FLEXIBLE. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE (ASSET # 58073103), DIGITAL MICROSCOPE (ASSET# 61059838). THE X-RAY USED MET ID# (B)(4). THE DHR REVIEW IS IN PROCESS. A COPY OF THE TOE WAS REQUESTED ON CD, BUT HAS NOT BEEN RECEIVED. A COPY OF THE OPERATIVE REPORT HAS BEEN RECEIVED. THE VALVE HAS BEEN GIVEN TO R&D FOR FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    REPORTEDLY, A 23MM VALVE WAS EXPLANTED AT IMPLANT DUE TO CENTRAL AORTIC REGURGITATION. PER THE (B)(6) 2011 OP REPORT RECEIVED ON (B)(6) 2011: THE VALVE LEAFLETS WERE EXCISED AND THE VALVE RING WAS DECALCIFIED. THE VALVE RING WAS SIZED AND A 23MM PERIMOUNT CARPENTIER EDWARDS VALVE WAS INSERTED USING 2/0 TYCRON SUTURES IN AN INTERRUPTED MATTRESS FASHION. THE VALVE WAS INSERTED SATISFACTORILY. THERE SEVERE SUB- AORTIC STENOSIS WAS ALSO EXCISED WITH DECALCIFICATION OF LVOT. DURING TERMINATION OF CARDIOPULMONARY BYPASS, I NOTED THAT THE AORTA HAD BECOME VERY FRAGILE AND THERE WAS SIGNIFICANT HAEMATOMA AND BLEEDING FROM ESSENTIALLY ALL AREAS OF THE AORTOTOMY. I ALREADY HAD SIGNIFICANT SUSPICIONS ABOUT THE QUALITY OF THE AORTA AND THEREFOR I ELECTED TO REESTABLISH BYPASS AND REPLACE THE ASCENDING AORTA ABOVE THE LEVEL OF THE VALVE STRUTS. THE AORTA WAS RE-CROSS CLAMPED. THE MYOCARDIUM WAS ARRESTED WITH ANTEGRADE BLOOD BASED CARDIOPLEGIC SOLUTION. THE STERNOTOMY WAS COMPLETED. THE ASCENDING AORTA WAS EXCISED JUST ABOVE THE VALVE STRUTS AND AS DISTAL AS POSSIBLE NEAR THE ARCH. THIS WAS REPLACED WITH A 28MM HEMASHIELD GRAFT WHICH WAS PERFORMED WITH CONTINUOUS 4/0 PROLENE SUTURE AT EACH END AND WAS STRENGTHENED WITH A TEFLON STRIP. DE-AIRING WAS STARTED AND THE AORTA WAS CROSS-CLAMPED. CARDIOPULMONARY BYPASS WAS DISCONTINUED ON 3 G/KG/MIN OF DOPAMINE WITH A BLOOD PRESSURE OF 120/60. AT THIS POINT TRANSOESOPHAGEAL ECHOCARDIOGRAM SHOWED MODERATE CENTRAL AORTIC REGURGITATION THROUGH THE VALVE. THERE WAS NO EVIDENCE OF PARAVALVULAR LEAK. I COULD NOT EXPLAIN THIS CENTRAL AORTIC VALVE REGURGITATION. I THEREFORE RE-CROSS CLAMPED THE AORTA. THE MYOCARDIUM WAS RE-ARRESTED. THE HEMASHIELD GRAFT WAS INCISED AND THE VALVE WAS INSPECTED AND APPEARED INTACT, HOWEVER, THE AR DETECTED BY TOE WAS SIGNIFICANT. I DECIDED TO EXPLANT THE PERIMOUNT VALVE AND REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 11D083

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R