BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 12025764 · Received June 18, 2021

    Report

    Report Number
    3006722112-2021-00060
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    May 19, 2021
    Product Code
    OCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: WE ARE UNABLE TO CONTACT THE AUTHOR OF THE LITERATURE REVIEW, ALTHOUGH WE ARE UNABLE TO CONFIRM THE ACTUAL DEVICE USED WE STILL WANT TO REPORT THE EVENT. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENT OF "OTHER-CLINICAL OUTCOME DEVICE RELATED" AS FOLLOWS: WARNINGS: ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING ABSORBABLE SUTURES BEFORE EMPLOYING SYNTHETIC ABSORBABLE SUTURES FOR WOUND CLOSURE, AS THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED. ENSURE THAT THERE IS SUFFICIENT SPACE FOR THE NEEDLE TO OPEN. WARNING: DO NOT INTRODUCE THE DEVICE WITH THE NEEDLE BODY IN ITS OPEN POSITION. ADVERSE EVENT: POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: PHARYNGITIS / SORE THROAT, NAUSEA AND / OR VOMITING, ABDOMINAL PAIN AND / OR BLOATING, HEMORRHAGE, HEMATOMA, CONVERSION TO LAPAROSCOPIC OR OPEN PROCEDURE, STRICTURE, INFECTION / SEPSIS, PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION, ESOPHAGEAL, COLONIC AND/OR PHARYNGEAL LACERATION, INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY, ASPIRATION, WOUND DEHISCENCE, ACUTE INFLAMMATORY TISSUE REACTION.

    Description of Event or Problem · 1

    BACKGROUND: DILATED GASTROJEJUNAL ANASTOMOSIS (GJA) IS AN ANATOMICAL CAUSE FOR WEIGHT REGAIN FOLLOWING ROUX-EN-Y GASTRIC BYPASS (RYGB) THAT CAN BE CORRECTED WITH DIAMETER REDUCTION THROUGH ENDOSCOPIC (ENDO) OR SURGICAL (SURG) REVISION. THE TRANSORAL OUTLET REDUCTION (TORE) ENDOSCOPIC REVISION TECHNIQUE IS ASSOCIATED WITH 8.8% TOTAL WEIGHT LOSS AT 5 YEARS WITH FEW ADVERSE EVENTS, HOWEVER DIRECT COMPARISON TO SURGICAL REVISION REMAINS UNKNOWN. THIS STUDY AIMS TO COMPARE SERIOUS ADVERSE EVENT (SAE) RATES AND WEIGHT LOSS PROFILES BETWEEN ENDO AND SURG REVISIONAL TECHNIQUES OVER A 5-YEAR PERIOD.METHODS: THIS IS A RETROSPECTIVE MATCHED COHORT STUDY OF RYGB PATIENTS WHO UNDERWENT ENDO OR SURG REVISION FOR WEIGHT REGAIN AT LEAST PARTIALLY ATTRIBUTABLE TO AN ENLARGED GJA (>12MM) AT TWO TERTIARY REFERRAL CENTERS. ENDO PATIENTS WERE MATCHED 1:1 TO SURG PATIENTS BASED ON AGE, SEX, BODY MASS INDEX (BMI) AND WEIGHT REGAIN. DEMOGRAPHICS, GJA SIZE, SERIOUS ADVERSE EVENTS (SAES) AND WEIGHT PROFILES WERE COLLECTED. THE PRIMARY OUTCOME WAS COMPARISON OF SAE RATES BETWEEN GROUPS. SECONDARY OUTCOMES INCLUDE COMPARISONS OF THE AMOUNT OF WEIGHT LOSS, REPORTED USING PERCENTAGE OF TOTAL WEIGHT LOSS (%TWL), AT 1, 3 AND 5 YEARS. A FISHER'S EXACT TEST WAS USED TO COMPARE RATE OF SAE'S AND STUDENT'S T-TEST WAS USED FOR WEIGHT COMPARISONS.RESULTS: A TOTAL OF 122 RYGB PATIENTS WITH WEIGHT REGAIN AND AN ENLARGED GJA (61 ENDO, 61 MATCHED SURG) WERE INCLUDED. AMONG THESE, 53 COMPLETED 5-YEAR FOLLOW-UP IN THE ENDO GROUP COMPARED TO 28 IN THE SURG GROUP. PRE-REVISION AGE, SEX, TIME SINCE RYGB, PERCENT WEIGHT REGAIN FROM INITIAL WEIGHT LOSS, WEIGHT, BMI AND GJA DIAMETER WERE SIMILAR BETWEEN GROUPS (TABLE 1). PRIMARY OUTCOME: THE SAE RATE IN THE ENDO GROUP (4.9%) WAS LOWER THAN THE SURG GROUP (26.2%); P=0.002. SAES WITHIN THE ENDO GROUP INCLUDED GJA STENOSIS REQUIRING BALLOON DILATION (1), ESOPHAGEAL PERFORATION REQUIRING ENDOSCOPIC CLIP CLOSURE (1) AND GASTROINTESTINAL BLEEDING (1). SAE'S WITHIN THE SURG GROUP INCLUDED LEAK (3), GJA STENOSIS REQUIRING BALLOON DILATION (2), INTRA-ABDOMINAL INFECTION (2), SUPERFICIAL WOUND INFECTION (2), ULCER (3), SEVERE ABDOMINAL PAIN (3), GASTROINTESTINAL BLEEDING (2) HIGH-GRADE SMALL BOWEL OBSTRUCTION (1), PANCREAS INJURY CAUSING PANCREATITIS (1), SUBCUTANEOUS NECK EMPHYSEMA (1) AND POST-OPERATIVE PULMONARY EMBOLISM (1). ALTHOUGH THE SURG GROUP EXPERIENCED SIGNIFICANTLY GREATER WEIGHT LOSS AT 1 YEAR, THERE WAS NO SIGNIFICANT DIFFERENCES AT 3 AND 5 YEARS (TABLE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924272 ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC SUTURING SYSTEM OCW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention