BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 3092450 · Received May 3, 2013

    Report

    Report Number
    2025587-2013-00070
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT WAS PROVIDED FOR ANALYSIS, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. CONCLUSION: REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED TO DISTRIBUTION. THERE WERE NO NON-CONFORMANCES, DEVIATIONS, REWORKS OR CORRECTIVE ACTIONS ASSOCIATED WITH THIS VALVE THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION; HOWEVER, BASED ON INFORMATION AVAILABLE THE USER CAUSED THE TEAR IN THE LEAFLET OF THE VALVE WITH A SHARP INSTRUMENT. (B)(6). (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 DURING IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PHYSICIAN NICKED THE RIGHT LEAFLET WITH A SUTURE NEEDLE AND TORE A HOLE. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER VALVE OF THE SAME MANUFACTURER. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194364 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA FR995

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention