BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 2861679 · Received December 7, 2012

    Report

    Report Number
    2031780-2012-00011
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE FILING THE INITIAL MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED RELATED TO THE PATIENT GENDER AND THE MONTH AND YEAR OF IMPLANT AND EXPLANT OF THE DEVICE. THE EVENT DESCRIPTION WAS UPDATED TO REFLECT THE NEW INFORMATION. THE CODING AND CONCLUSION OF THE INITIAL MEDWATCH FILED IS STILL ACCURATE BASED ON THIS NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS/INVESTIGATION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IN ADDITION, NO SERIAL NUMBER WAS PROVIDED, SO A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE VALVE WAS EXPLANTED DUE TO BROKEN SUTURE. BROKEN SUTURES ARE USUALLY RELATED TO USER TECHNIQUE, AND MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED FOUR YEARS, WAS EXPLANTED DUE SEVERE AORTIC INSUFFICIENCY AND PRESENTATION OF CONGESTIVE HEART FAILURE. IT WAS DISCOVERED DURING EXPLANT THAT A SUTURE WAS BROKEN AT THE CONTINUOUS SUTURE LINE, WHICH HAD RESULTED IN DEHISCENCE. IT WAS REPORTED THAT THE VALVE WAS OTHERWISE IN GOOD CONDITION. THE VALVE WAS SUCCESSFULLY REPLACED WITH A STENTED VALVE IN ADDITION TO MITRAL VALVE REPAIR DUE TO SEVERE MITRAL REGURGITATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED AN UNKNOWN DURATION, WAS EXPLANTED DUE TO A BROKEN SUTURE, WHICH HAD RESULTED IN DEHISCENCE. A COMPANY REPRESENTATIVE REPORTED THAT THE EXPLANT HAD OCCURRED APPROXIMATELY ONE TO TWO YEARS BEFORE THE REPRESENTATIVE HAD FIRST LEARNED OF THE EXPLANT, SO NO ADDITIONAL DETAILS WERE IMMEDIATELY AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R