BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC FLEX

    MDR report key: 3041000 · Received April 8, 2013

    Report

    Report Number
    2134151-2013-00011
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    August 7, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO MEDTRONIC. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. IT WAS REPORTED THAT A CUTTING NEEDLE WAS USED FOR THE ATTEMPTED SUTURING OF THE VALVE. THE INSTRUCTIONS FOR USE (IFU) HAS A WARNING THAT STATES "WHEN SECURING THE VALVE IN PLACE, SUTURE NEEDLES SHOULD BE PASSED THROUGH THE OUTER HALF OF THE SEWING CUFF AND SUTURE ENDS SHOULD BE CUT SHORT AFTER THE KNOTS ARE TIED. IT IS SUGGESTED THAT ONLY TAPER POINT NEEDLES BE USED FOR SUTURING THE CUFF AS TAPER CUT OR OTHER CUTTING NEEDLES MAY CUT THE CUFF FIBERS". FROM THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE VALVE MAY NOT HAVE BEEN SEWN IN THE OUTER HALF OF THE SEWING CUFF AND THAT A CUTTING NEEDLE CUT THROUGH THE VALVE SUTURE, CAUSING THE SEWING RING TO SEPARATE. 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

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE SERIAL NUMBER WAS VERIFIED TO BE CORRECT. VISUAL INSPECTION OF THE SEWING CUFF SHOWED THE LOOSE ENDS OF THE SUTURE WERE SEVERELY FRAYED AND APPEARED TO HAVE BEEN CUT BY THE SURGEON. THE CARBON WAS VISUALLY INSPECTED WITH NO ANOMALIES NOTED. THE LEAFLETS WERE FULLY MOBILE. NO OTHER DEVICE ANOMALIES WERE FOUND. (B)(6).

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. PRODUCT RETURN HAS BEEN REQUESTED. (B)(6). (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 DURING THE ATTEMPTED IMPLANT OF THIS MECHANICAL HEART VALVE, A SEPARATION OF THE SEWING RING WAS OBSERVED AS THE PHYSICIAN BEGAN SUTURING THE VALVE INTO PLACE. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE WITH NO ADVERSE PATIENT EFFECTS. IT WAS REPORTED THAT A CUTTING NEEDLE WAS USED FOR THE ATTEMPTED SUTURING. IT WAS NOT KNOWN IF THE VALVE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143513 AORTIC FLEX HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 500FA23

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention