BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TICRON

    MDR report key: 12624092 · Received October 13, 2021

    Report

    Report Number
    9612501-2021-01692
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    January 8, 2021
    Report Date
    October 13, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LONG-TERM RESULTS OF TRICUSPID ANNULOPLASTY WITH 3-DIMENSIONAL-SHAPED RINGS: EFFECTIVE AND DURABLE. SOURCE: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 60 (2021) 115¿121. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2011 AND DECEMBER 2014, POSTOPERATIVE TO TRICUSPID VALVE REPAIR WITH 3D-SHAPED RINGS, COMPLICATIONS INCLUDED RING DEHISCENCE ON 2 PATIENTS. THERE WERE ALSO 17 CASES OF RECURRENT TRICUSPID REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520043 UNKNOWN TICRON SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT DAVIS & GECK CARIBE LTD UNKNOWN TICRON

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O