BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HEART VALVES DIVISION

    MDR report key: 5394784 · Received January 27, 2016

    Report

    Report Number
    2025587-2016-00092
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    December 23, 2015
    Report Date
    January 8, 2016
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT HAS BEEN REQUESTED; HOWEVER, THIS INFORMATION WAS NOT AVAILABLE. PRODUCT ANALYSIS: THE PRODUCT SPECIMEN HAS BEEN DISCARDED BY THE MEDICAL INSTITUTION. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THIS VALVE WAS EXPLANTED. UPON EXPLANTING THE VALVE, THE PHYSICIAN NOTED THAT THE STRUTS OF THE VALVE WERE BENT INWARD DUE TO THE CLOSURE OF THE AORTA, INDICATING THE ANNULUS WAS TOO SMALL FOR THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53308 MEDTRONIC HEART VALVES DIVISION HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305U

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention