BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOCITY PORT WITH GAST BAND

    MDR report key: 11167639 · Received January 13, 2021

    Report

    Report Number
    3005075853-2021-00267
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    March 1, 2020
    Report Date
    December 28, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2021. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. COMPLICATIONS WE DESCRIBED HAD WASN'T RESULTS OF CONCRETE ETHICON'S DEVICE. WE ARE SURE OF THAT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: EXACT DATE UNKNOWN, CAPTURED AS CITATION DATE. BATCH # UNK. (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: IS IT POSSIBLE TO IMPROVE LONG-TERM RESULTS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING WITH APPROPRIATE PATIENT SELECTION? AUTHOR: MICHAL ORLOWSKI, MICHAL JANIK, PAULA FRANCZAK, AGATA FRASK, MACIEJ MICH. CITATION: VIDEOSURGERY MINIINV 2020; 15 (1): 166¿170. DOI: HTTPS://DOI.ORG/10.5114/WIITM.2019.86773. THE AIM OF THIS RETROSPECTIVE STUDY IS TO ASS THE LONG-TERM CLINICAL OUTCOMES OF PATIENTS WHO UNDERWENT INSERTION OF LAPAROSCOPIC ADJUSTABLE GASTRIC BAND (LAGB). BETWEEN 2004 AND 2009, 162 PATIENTS (FEMALE N=123, MALE N=39, MEAN PREOPERATIVE WEIGHT N=137.1KG AND MEAN PREOPERATIVE BMI WAS 48 KG/M2) UNDERWENT LAGB AND WERE INCLUDED IN THE STUDY ANALYSIS. PROCEDURE WAS PERFORMED WITH SWEDISH ADJUSTABLE GASTRIC BAND- BD2XV WITH VELOCITY INJECTION PORT AND APPLIER (ETHICON), APPLYING THE ¿PARS FLACCIDA¿ TECHNIQUE. PATIENTS UNDERWENT GASTRIC BAND REMOVAL BECAUSE OF SLIPPAGE (N=8), BAND INFECTION (N=8), INTOLERANCE (N=3), BAND EROSION (N=1), OTHER (N=1) AND BECAUSE THEY WERE NOT SATISFIED WITH THE RESULT (N=12). UNSUCCESSFUL OUTCOME WAS ALSO REPORTED (N=45). THIS STUDY FOUND THAT LAGB WAS NOT AN EFFECTIVE BARIATRIC PROCEDURE IN LONG-TERM OBSERVATION. ONLY 25% OF 125 PATIENTS WHO MAINTAINED A FUNCTIONING BAND ACHIEVED %EWL > 50%. COMPLIANCE WAS THE ONLY INDEPENDENT PROGNOSTIC FACTOR FOR WEIGHT LOSS. OTHER FACTORS HAD NO INFLUENCE ON OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63059 VELOCITY PORT WITH GAST BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention