BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2013241 · Received March 8, 2011

    Report

    Report Number
    2024601-2011-00190
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    September 15, 2009
    Report Date
    February 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED FOR ANALYSIS. BASED UPON THE IMPLANT DATE RANGE OF (B)(6) 2000 TO (B)(6) 2008, PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS EITHER A TAPER I OR TAPER II. HEMORRHAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMORRHAGE AND THROMBOSIS AS FOLLOWS: "ADVERSE EVENTS: PERFORATION OF THE STOMACH CAN OCCUR. DEATH CAN ALSO OCCUR. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND." "THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PTS WITH POTENTIAL UPPER GASTROINTESTINAL BLEEDING CONDITIONS SUCH AS ESOPHAGEAL OR GASTRIC VARICES OR CONGENITAL OR ACQUIRED INTESTINAL TELANGIECTASES." PT EXCLUSION CRITERIA: SEVERE COAGULOPATHY, UPPER GASTROINTESTINAL BLEEDING CONDITIONS SUCH AS ESOPHAGEAL OR GASTRIC VARICES, CONGENITAL OR ACQUIRED INTESTINAL TELANGIECTASIA."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENT OF HEMORRHAGE FROM JOURNAL ARTICLE, "THE EFFECTIVENESS OF ADJUSTABLE GASTRIC BANDING: A RETROSPECTIVE 6-YEAR U.S. FOLLOW-UP STUDY", SURG ENDOSC (2011) 25:397-403. THIS MEDWATCH REPRESENTS THE 5 PTS LISTED IN TABLE 4 OF THE ARTICLE WHO WERE DIAGNOSED WITH (4) HEMORRHAGE AND (1) DEEP VEIN THROMBOSIS (DVT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention