BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 12690516 · Received October 25, 2021

    Report

    Report Number
    3003910212-2021-01305
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    November 30, 2012
    Report Date
    October 25, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FTM
    PMA / PMN Number
    K030782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿LAPAROSCOPIC GASTRIC BYPASS VERSUS LAPAROSCOPIC SLEEVE GASTRECTOMY AS A DEFINITIVE SURGICAL PROCEDURE FOR MORBID OBESITY. MID-TERM RESULTS¿ OBES SURG (2013) 23:292¿299 DOI 10.1007/S11695-012-0828-4 DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. THE DATE OF EVENT IS UNKNOWN, THEREFORE THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE WILL BE USED. ADDITIONALLY, EVENT INFORMATION SUCH AS ITEM/LOT NUMBER, IMPLANT DATE, DATE OF EXPLANT, PATIENT MEDICAL HISTORY WAS REQUESTED, HOWEVER NO INFORMATION HAS BEEN RECEIVED. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT, POSSIBLE ADVERSE REACTIONS MAY INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, INFLAMMATION, ADHESIONS AND HEMATOMA. USE OF THIS PRODUCT IN APPLICATIONS OTHER THAN THOSE INDICATED HAS THE POTENTIAL FOR SERIOUS COMPLICATIONS. POTENTIAL COMPLICATIONS INCLUDE: INADEQUATE REINFORCEMENT STRENGTH, STAPLE PULLOUT, INFECTION, ABRASION, MIGRATION AND EROSION. THE USE OF GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WILL INCREASE THE THICKNESS OF THE AREA TO BE STAPLED BY APPROXIMATELY 0.30 MM. STAPLING TECHNIQUE SHOULD REFLECT THE THICKNESS OF THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT SUCH THAT THE TOTAL THICKNESS OF MATERIAL TO BE STAPLED FALLS WITHIN THE RECOMMENDED RANGE FOR THE STAPLER (SEE STAPLER INSTRUCTIONS FOR USE). USE OF STAPLES WITH INSUFFICIENT LENGTH FOR THE PROCEDURE PERFORMED MAY LEAD TO DISRUPTION OF THE STAPLE LINE DUE TO INADEQUATE STAPLE CLOSURE. USE OF GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT ON STAPLER SIZES INCONSISTENT WITH THE PRODUCT LABELING HAS THE POTENTIAL TO CAUSE SERIOUS COMPLICATIONS. THESE COMPLICATIONS INCLUDE STAPLE PULLOUT, DISRUPTION OF THE ANASTOMOSIS AND THE INABILITY TO REMOVE THE STAPLER FROM THE ANASTOMOSIS AFTER FIRING.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿LAPAROSCOPIC GASTRIC BYPASS VERSUS LAPAROSCOPIC SLEEVE GASTRECTOMY AS A DEFINITIVE SURGICAL PROCEDURE FOR MORBID OBESITY. MID-TERM RESULTS¿ THE ARTICLE WAS PUBLISHED NOVEMBER 30, 2012. PER THE ARTICLE: BUTTRESS MATERIAL WAS USED FOR STAPLE LINE REINFORCEMENT USING GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT (SEAMGUARD® STAPLE LINE REINFORCEMENT MATERIAL, W.L. GORE &ASSOCIATES, ARIZ, USA). BACKGROUND: LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) HAS BEEN GAINING ACCEPTANCE BECAUSE IT HAS SHOWN GOOD SHORTAND MID-TERM RESULTS AS A SINGLE PROCEDURE FOR MORBID OBESITY. THE AIM OF THIS STUDY WAS TO COMPARE SHORT- AND MIDTERM RESULTS BETWEEN LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) AND LSG. METHODS: OBSERVATIONAL RETROSPECTIVE STUDY FROM A PROSPECTIVE DATABASE OF PATIENTS UNDERGOING LRYGB AND LSG BETWEEN 2004 AND 2011, WHERE 249 PATIENTS (MEAN AGE 44.7 YEARS) WERE INCLUDED. RESULTS: ONE HUNDRED THIRTY-FIVE LRYGB AND 114 LSG WERE INCLUDED. SIGNIFICANT STATISTICAL DIFFERENCES BETWEEN LRYGB AND LSG WERE FOUND IN OPERATIVE TIME (153 VS. 93 MIN. P< 0.001), MINOR POSTOPERATIVE COMPLICATIONS (21.5 % VS. 4.4 %, P00.005), BLOOD TRANSFUSIONS (8.8 % VS. 1.7 %, P0. PER THE ARTICLE: GASTRIC LEAK IN TWO, ONE TREATED BY RESTAPLING THE LEAK SITE AND THE SECOND BY PLACING AN ABDOMINAL DRAIN. TWO (1.7 %) IN THE LSG REQUIRED RE-OPERATION BECAUSE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588389 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O