BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 2863817 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18806
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, 2 COMMISSURES APPEARED BENT AND FACING INWARD. DUE TO THE CURRENT CONDITION OF THE VALVE, PROFILE HEIGHT OF THE VALVE COULD NOT BE MEASURED. NO VISIBLE DAMAGE WAS OBSERVED ON LEAFLETS. METHOD: X-RAY.

    Additional Manufacturer Narrative · 1

    MODEL #: 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. METHOD/CONCLUSION: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE HAS BEEN RECEIVED BY OUR WAREHOUSE IN (B)(4) AND IS CURRENTLY IN TRANSIT TO OUR EVALUATION LAB IN (B)(4) FOR EVALUATION. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    REPORTEDLY THE DEVICE WAS EXPLANTED AT IMPLANT. THE SURGEON DESCRIBES THAT THE STENT POSTS HAVE DIFFERENT HIGHTS. NOT COMPETENT CLOSING OF LEAFLETS., MAY HAVE FORCED THE VALVE DURING IMPLANTATION. (B)(6) 2012, THROUGH A FOLLOW UP WITH THE SALES REP IT WAS LEARNED THAT THE ISSUE WAS DETECTED WHILE THE PATIENT WAS ALREADY DECANNULATED, TAKEN OFF CPB. PER THE SURGEON'S EMAIL: "I REOPERATED A PATIENT WHO HAD A BIOPROSTHETIC AORTIC VALVE (26 MM BIOCOR) IN 1996. HE WAS NOW IN HEARTFAILURE DUE TO SVD AND ALSO HAD SEVERE TI. THE DAMAGED VALVE WAS EXCISED WITHOUT PROBLEMS AND A PERIMOUNT 25 MM WAS SEWN IN. WHEN IT WAS IN PLACE I SAW THAT ONE STRUT WAS OUT OF LINE, RESULTING IN MALCOAPTATION OF THE CUSPS. I HAVE NO RECOLLECTION OF HARMING THE VALVE OR HAVING TO TREAT I FORCEFULLY DURING IMPLANTATION. MY FEELING WAS THAT THE PROBLEM MIGHT BE SOLVED WHEN THE ROOT WOULD BE PRESSURISED AFTER DECLAMPING. I DID SO AND REPAIRED THE TI. AFTER WEANING FROM BYPASS IT WAS APPARENT THAT THERE WAS LEAKAGE, AT LEAST >1/4, PROBABLY 2/4. IT WAS HARD FOR THE ECHOCARDIOGRAPHER TO EXACTLY CHARACTERIZE WHAT THE PROBLEM WAS. HE COULD NOT TELL FOR SURE WETHER IT WAS PARAVALVULAR OR FROM MALCOAPTATION OF THE CUSPS. I DECIDED TO RECLAMP AND HAVE A LOOK. WHEN ANALYSING, I DID NOT IDENTIFY ANY PARAVALVULAR PROBLEM AND THE STRUT WAS STILL MALALIGNED, SO I DECIDED TO EXCHANGE IT. I DID WITH AN IDENTICAL VALVE, AND IT WAS LATER CONFIRMED TO WORK NORMALLY AS EXPECTED, WITHOUT AI. WE SEND THE FIRST VALVE TO YOU FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 3463300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R