BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    MDR report key: 4799021 · Received May 27, 2015

    Report

    Report Number
    3003910212-2015-00025
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 27, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K053200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DESCRIBE EVENT OR PROBLEM : CLARIFIED WHY THIS EVENT WAS REPORTED. ADDITIONAL MANUFACTURER NARRATIVE: NARRATIVE/CORRECTED DATA : ARTICLE CITATION (PREVENTING COMPLICATIONS IN COLORECTAL ANASTOMOSIS: RESULTS OF A RANDOMIZED CONTROLLED TRAIL USING BIOABSORBABLE STAPLE LINE REINFORCEMENT FOR CIRCULAR STAPLER; DIS COLON RECTUM 2014; 57: 1195-1201).

    Additional Manufacturer Narrative · 1

    GORE REQUESTED SPECIFIC INFORMATION FROM THE ARTICLE AUTHOR. THE ARTICLE AUTHOR REPORTED TO GORE THAT NO ADVERSE EVENT OR MORBIDITY DIRECTLY RELATED WITH THE USE OF THE REINFORCEMENT DEVICE WAS OBSERVED, AND COULD NOT COMPLY WITH THE REQUEST FOR SPECIFIC INFORMATION. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITERATURE (PREVENTING COMPLICATIONS IN COLORECTAL ANASTOMOSIS: RESULTS OF A RANDOMIZED CONTROLLED TRAIL USING BIOABSORBABLE STAPLE LINE REINFORCEMENT FOR CIRCULAR STAPLER; DIS COLON RECTUM 2014; 57: 1195-1201) THAT 148 PATIENTS RECEIVED THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT (CIRCULAR). ANASTOMOTIC LEAK, SEVER BLEEDING, ANASTOMOTIC STENOSIS, RE-OPERATION, ANASTOMOTIC COMPLICATIONS WERE IDENTIFIED WITHIN THE ARTICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE IN A LITERATURE ARTICLE THAT 10 PATIENTS WHO RECEIVED THE GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT (CIRCULAR) EXPERIENCED RE-OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344495 GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL FTM W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other