BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 16993623 · Received May 24, 2023

    Report

    Report Number
    3013508647-2023-00370
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    December 6, 2018
    Report Date
    May 24, 2023
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING, AND AS ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE MADE. AT THIS TIME, THE REPORTED ISSUE WILL BE TRACKED AND TRENDED. A2: AGE OF STUDY SUBJECTS WAS 41.9 +/- 11.3 YEARS. A3: SEX OF STUDY SUBJECTS: 662 MALE, 2904 FEMALE. A4: WEIGHT OF STUDY SUBJECTS: 112.0 +/- 20.3 KG. D6A: STUDY EXAMINED OUTCOMES FOR BANDS IMPLANTED BETWEEN OCTOBER 1995 TO FEBRUARY 2018, BUT DIDN'T IDENTIFY EXACT DATES FOR THE 3697 IMPLANTED DEVICES.

    Description of Event or Problem · 0

    LITERATURE REVIEW PERFORMED: LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING ON 3566 PATIENTS UP TO 20-YEAR FOLLOW-UP: LONG-TERM RESULTS OF A STANDARDIZED TECHNIQUE NICCOLÒ FURBETTA(1), MD; FRANCESCA GRAGNANI(2), MD; GIUSEPPE FLAUTI(2), MD; FRANCESCO GUIDI(3),MD; FRANCESCO FURBETTA(2), MD. 1 - GENERAL SURGERY, DEPARTEMENT OF SURGERY, UNIVERSITY OF PISA, ITALY. 2 - GENERAL AND LAPAROSCOPIC SURGERY, CLINIC "LEONARDO", SOVIGLIANA-VINCI (FIRENZE), ITALY. 3 - ANESTHESIOLOGIST, CLINIC "LEONARDO", SOVIGLIANA-VINCI (FIRENZE), ITALY. SURGERY FOR OBESITY AND RELATED DISEASES 15 (2019) 409-416 HTTPS://DOI.ORG/10.1016/J.SOARD.2018.12.012. THIS PUBLISHED ARTICLE DESCRIBED A SINGLE-SURGEON RETROSPECTIVE REVIEW OF 3566 PATIENTS WHO UNDERWENT LAGB IMPLANT SURGERY FROM OCTOBER 1995 TO FEBRUARY 2018. DATA WERE RETRIEVED FROM A PROSPECTIVELY-COLLECTED COMPUTER DATABASE AND RETROSPECTIVELY ANALYZED. FURTHERMORE, PATIENTS WERE STRATIFIED ACCORDING TO BODY MASS INDEX (BMI) AND AGE AND RESULTS ARE EVALUATED FOR EACH SUBGROUP. THE AIM OF THIS STUDY WAS TO PRESENT THE CLINICAL SITE'S EXPERIENCE IN LAGB AS THE FIRST SURGICAL APPROACH OVER A PERIOD OF >20 YEARS ON 3566 OBESE PATIENTS, AND TO INVESTIGATE THE OUTCOMES IN TERMS OF EFFICACY, COMPLICATIONS, AND REOPERATIONS. RESULTS. ALL THE OPERATIONS WERE PERFORMED LAPAROSCOPICALLY WITHOUT ANY MORTALITY AND/OR MAJOR SPECIFIC COMPLICATIONS. NINE HUNDRED TWENTY-SIX PATIENTS (71.6%) COMPLETED AT LEAST 10 YEARS FOLLOW-UP AND 180 (58.4%) REACHED 15-YEAR FOLLOW-UP. THERE WAS A MEAN OF 49%, 52.6% AND 59.2% OF EXCESS WEIGHT LOSS (%EWL) AT 10-, 15 AND 20-YEARS, RESPECTIVELY. MAJOR LATE COMPLICATIONS WERE POUCH HERNIATION-DILATION (5.8%) AND EROSION (2.5%): BOTH SOLVED BY A REPLICABLE, LESS INVASIVE OPERATION. TOTAL REOPERATION RATE WAS 24.1%. PUBLISHED: 06DEC2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089418 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 49.9 YR Female Required Intervention| O