BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 21975931 · Received May 7, 2025

    Report

    Report Number
    3005075853-2025-03440
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    January 22, 2021
    Report Date
    May 7, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/7/2025. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPT MADE TO OBTAIN THE FOLLOWING. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED. SHOULD FURTHER DETAILS BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PHILLIPS E, PONCE J, BHOYRUL S, CUNNEEN SA, GOMEZ E, JACOBS M, KIPNES M, MAREMA RT, SCHWIERS M, WAGGONER JR, DEMARCHI J. SAFETY AND EFFECTIVENESS OF REALIZE ADJUSTABLE GASTRIC BAND: 5-YEAR PROSPECTIVE STUDY. SURG OBES RELAT DIS. 2021 MAY;17(5):956-962. DOI: 10.1016/J.SOARD.2021.01.019. EPUB 2021 JAN 22. PMID: 33674199; PMCID: PMC7826021. THE AIM OF THIS STUDY IS TO PRESENT 5-YEAR SAFETY AND EFFECTIVENESS DATA FOR THE REALIZE GASTRIC BAND (MANUFACTURED BY ETHICON ENDO-SURGERY, INC.), AS DIRECTED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA). THE PRIMARY OBJECTIVE WAS TO ASSESS THE 5-YEAR REALIZE GASTRIC BAND REOPERATION RATE, INCLUDING BAND REVISIONS, REPLACEMENTS, AND EXPLANTATIONS, RESULTING FROM SERIOUS ADVERSE DEVICERELATED EVENTS. THE SECONDARY (EFFECTIVENESS) OBJECTIVES WERE TO EVALUATE CHANGES IN EXCESS WEIGHT, QUALITY OF LIFE, GLYCATED HEMOGLOBIN (HBA1C) LEVELS, AND SERUM LIPID LEVELS 5 YEARS AFTER IMPLANTATION OF THE REALIZE GASTRIC BAND. A TOTAL OF 303 PATIENTS, WHO WERE THEN ASSESSED ON AN ANNUAL BASIS, WITH 231 PATIENTS COMPLETING 5 YEARS OF FOLLOW-UP. THE FINAL STUDY VISIT WAS COMPLETED ON JANUARY 12, 2015. 61 MALE AND 242 FEMALE PATIENTS BETWEEN 18 AND 60 YEARS OF AGE (INCLUSIVE), RACE ( CAUCASIAN, NOT OF HISPANIC ORIGIN 205 (67.7) ; ASIAN/PACIFIC ISLANDER 8 (2.6) ; BLACK, NOT OF HISPANIC ORIGIN 27 (8.9) ; HISPANIC 55 (18.2) ; OTHER 8 (2.6 )) WHO WERE CONSIDERED APPROPRIATE CANDIDATES FOR A SURGICAL WEIGHT LOSS INTERVENTION (BODY MASS INDEX [BMI] OF >40 KG/M2 AND =55 KG/M2 , OR A BMI =35 KG/M2 AND ,<40 KG/ M2 WITH =1 CO-MORBID CONDITIONS) WERE CONSIDERED FOR INCLUSION IN BOTH THE INITIAL PMA AND EXTENSION COHORTS, AS WELL AS THE PARALLEL POSTMARKET STUDY COHORT. THE REALIZE ADJUSTABLE GASTRIC BANDS, ALSO KNOWN AS THE SWEDISH ADJUSTABLE GASTRIC BANDS OR THE CURVED ADJUSTABLE GASTRIC BANDS (ETHICON ENDO-SURGERY, CINCINNATI, OH), WERE IMPLANTED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE. REPORTED COMPLICATIONS ARE : REALIZE ADJUSTABLE GASTRIC BANDS (ETHICON ENDO-SURGERY) -CATHETER-RELATED INFECTIONS (N=14) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -BAND SLIPPAGE (N=21) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -EROSIVE GASTRITIS DUE TO BAND EROSION (N=4) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -VOMITING/FORCIBLE LOSS OF STOMACH CONTENTS DEEMED RELATED TO THE STUDY DEVICE (N=5) TREATMENT: NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION. -PORT DISPLACEMENT (N=3) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -GASTRIC DILATIONA (N=7) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -HIATAL HERNIAC (N=5) TREATMENT: "NOT SPECIFIED, BUT THE ARTICLE STATED THAT "THERE WERE 27 QUALIFIED REOPERATIONS THAT FIT THE PROTOCOL DEFINITION." -UNKNOWN COMPLICATIONS (N=9) TREATMENT: EARLY BAND REMOVAL - UNKNOWN SERIOUS ADVERSE EVENT (N-3) TREATMENT: REMOVAL OF GASTRIC BAND - LACK OF EFFECTIVENESS (N=1) TREATMENT: LEADING TO EXPLANT OR ADDITIONAL OBESITY SURGICAL PROCEDURE. IN CONCLUSION, POSTMARKET SAFETY STUDY HAD A REOPERATION RATE OF (B)(4), WHICH DID NOT MEET THE ARBITRARY, PREDETERMINED SAFETY SUCCESS CRITERION OF (B)(4). EVEN SO, THE GENERAL SAFETY PROFILE, REOPERATION RATE, AND EFFECTIVENESS ENDPOINTS THAT WERE OBSERVED IN THIS STUDY ARE CONSISTENT WITH THOSE REPORTED IN CURRENT LITERATURE. NO UNEXPECTED FINDINGS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485374 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention