BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC AP

    MDR report key: 2972323 · Received February 21, 2013

    Report

    Report Number
    2134151-2013-00006
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT A CUTTING NEEDLE (TRIANGULAR SUTURE NEEDLE) WAS USED. WITHOUT THE SERIAL NUMBER OF THE PRODUCT NO DEVICE HISTORY COULD BE PULLED AND REVIEWED. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE OF THE CLINICAL OBSERVATION CANNOT BE DETERMINED. HOWEVER, GIVEN THE INFORMATION SUPPLIED, IT IS LIKELY THAT THE VALVE WAS NOT SEWN IN THE OUTER HALF OF THE SEWING CUFF PER THE INSTRUCTIONS FOR USE (IFU) AND THAT THE CUTTING NEEDLE CUT THROUGH THE VALVE STITCHING, CAUSING THE CUFF TO SEPARATE. BECAUSE THE VALVE CUFF STITCHING IS KNOTTED AT EVERY QUARTER OF THE CUFF'S CIRCUMFERENCE, THE CUFF WILL SEPARATE FOR APPROXIMATELY ONE CENTIMETER AND THEN STOP AT A KNOT IF THE STITCHING IS CUT OR BROKEN. THE IFU ALSO ADVISES USE OF ONLY TAPER POINT NEEDLES FOR SUTURING THE CUFF. SHOULD THE PRODUCT BE RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL BE RE-OPENED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    WITHOUT THE SERIAL NUMBER OF THE PRODUCT NO DEVICE HISTORY COULD BE PULLED AND REVIEWED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IT HAS BEEN REPORTED THAT THE VALVE IS TO BE RETURNED FOR ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE ATTEMPTED AORTIC IMPLANT OF THIS MECHANICAL HEART VALVE WAS ABANDONED WHEN A ONE CENTIMETER LONG TEAR WAS OBSERVED IN THE VALVE'S SEWING CUFF WHILE THE VALVE WAS BEING SUTURED INTO PLACE. ANOTHER MANUFACTURER'S VALVE WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75724 AORTIC AP HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 505DA22 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention