BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 7181718 · Received January 10, 2018

    Report

    Report Number
    MW5074530
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 9, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A RADIOLOGY PT WAS HAVING AN MRI OF THE LEFT KNEE. PT STATED SHE HAS PULMONARY ATRESIA. SHE STATED SHE HAS A (B)(4) TRANSCATHETER HEART VALVE (MRI CONDITIONAL 8). PT DID NOT BRING HER IMPLANT MRI CARD TO HAVE THE MRI. MRI TECHNOLOGIST CALLED THE PHYSICIAN, WHICH STATED THAT IT WAS OKAY FOR THE PT TO BE PUT IN THE MRI MACHINE. ONCE SCAN STARTED THE PT STATED HAD IMMEDIATE CHEST PAIN. IMMEDIATELY TOOK PT OUT OF SCAN ROOM, TOOK HER VITALS IN THE ARTHROGRAM ROOM. HR (B)(6)-BP (B)(6)- 02:100 AT 1745. CHARGE TECH IMMEDIATELY WENT TO OPERATING ROOM FOR NURSE. THE NURSE CHECKED PT STILL HAVING SOME PAIN. THE CHARGE WENT TO GET PHYSICIAN. PT WAS ASSESSED HR (B)(6)-BP (B)(6)- 02:100. AT 1800, PT WAS BROUGHT TO THE INJURY CLINIC FOR MONITORING. PT STATED SHE WAS FEELING FINE. DR TALK TO PT AND GRANDMOTHER THAT IF SHE STARTS HAVING ANY KIND OF PAIN TO GO IMMEDIATELY TO THE ER. PT WAS IN GOOD SPIRITS WHEN SHE LEFT. PT ALSO HAS STERNAL WIRES FROM OPEN HEART SURGERY. CHEST PAIN WAS OF UNCLEAR ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24987 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention