BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 5140350 · Received October 9, 2015

    Report

    Report Number
    3004478276-2015-00045
    Event Type
    Injury
    Date Received
    October 9, 2015
    Report Date
    September 11, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION ABOUT DEVICE EXPLANT OR TAVI PROCEDURE, DEVICE MODEL OR SERIAL NUMBER OR CLINICAL HISTORY OF THE PATIENT IS RECIEVED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED THE INFORMATION THAT TAVI RE-OPERATION WAS PERFORMED ON THE PATIENT AND PATIENT IS FEMALE IN HER (B)(6) (EXACT AGE IS UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED ABOUT THE DEVICE. CORRECTED THE PMA/510(K) TO P060038/S002. CHANGED CONCLUSION CODE SINCE DEVICE IS NOT GOING TO BE RETURNED DUE TO TAVI RE-OPERATION PERFORMED ON THE PATIENT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE MANUFACTURE RECEIVED THE INFORMATION THAT A MITROFLOW VALVE MAY BE EXPLANTED. STILL UNKNOWN IF THE VALVE WILL BE EXPLANTED OR TAVI WILL BE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    UPDATE: MANUFACTURER RECEIVED THE INFORMATION THAT TAVI RE-OPERATION WAS PERFORMED ON THE PATIENT AND PATIENT IS FEMALE IN HER (B)(6) (EXACT AGE IS UNKNOWN) AND IT WAS ALSO INDICATED THAT DEVICE MODEL IS POSSIBLY LXA MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671841 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention