BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR ANNULOPLASTY BAND

    MDR report key: 6674892 · Received June 28, 2017

    Report

    Report Number
    2025587-2017-01055
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    April 1, 2017
    Report Date
    July 25, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K980534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC ENGINEERS IDENTIFIED THE 63 MM MEDTRONIC POSTERIOR ANNULOPLASTY BAND AS MODEL H607M63. THE PRODUCT INFORMATION HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    CITATION: MORI M. RUPTURE OF GORE-TEX NEOCHORDAE 10 YEARS AFTER MITRAL VALVE REPAIR. J THORAC DIS. 2017 APR;9(4):E343-E345. DOI: 10. 21037/JTD.2017.03.64. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN B3. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 VIA LITERATURE OF A (B)(6) YEAR-OLD MALE PATIENT WITH SEVERE MITRAL REGURGITATION TEN YEARS AFTER THE IMPLANT OF A 63MM MEDTRONIC POSTERIOR ANNULOPLASTY BAND (SERIAL NUMBER NOT PROVIDED) AND MITRAL LEAFLET REPAIR. THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND ECHOCARDIOGRAM REVEALED A FLAILING ANTERIOR LEAFLET. THE BAND WAS EXPLANTED AND WAS NOTED TO INCOMPLETELY ENDOTHELIALIZED. THE BAND WAS ANCHORED AT THE RIGHT TRIGONE AND 2CM SHORT OF THE LEFT TRIGONE. SUBSEQUENTLY, THE NEOCHORDAE INSERTED AT THE A2 SCALLOP HAD RUPTURED IN THE MIDDLE. A 27MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED) WAS IMPLANTED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454156 POSTERIOR ANNULOPLASTY BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION H607M63

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention