BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX UNKNOWN

    MDR report key: 8691454 · Received June 12, 2019

    Report

    Report Number
    2210968-2019-82653
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    May 15, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (STRATAFIX SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (STRATAFIX SUTURE) USED IN THIS PROCEDURE? PLEASE CONFIRM WITH THE AUTHORS THE SPECIFIC NUMBER OF PATIENTS IN BOTH GROUPS WHO USED STRATAFIX (ETHICON) WHILE UNDERGOING GASTROJEJUNOSTOMY CITATION: OBESITY SURGERY. 2018; 28: 1838¿1844. DOI: HTTPS://DOI.ORG/10.1007/S11695-017-3094-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BIDIRECTIONAL JEJUNOJEJUNAL ANASTOMOSIS PREVENTS EARLY SMALL BOWEL OBSTRUCTION DUE TO THE KINKING AFTER CLOSURE OF THE MESENTERIC DEFECT IN THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS". AUTHORS: PIERRE MUNIER, HEFZI ALRATROUT, IOLE SICILIANO, PHILIPPE KELLER. CITATION: OBESITY SURGERY. 2018; 28: 1838¿1844. DOI: HTTPS://DOI.ORG/10.1007/S11695-017-3094-7. THE CLOSURE OF THE MESENTERIC DEFECTS (CMD) IN ROUX-EN-Y GASTRIC BYPASS (RYGB) REDUCES THE RISK OF SMALL BOWEL OBSTRUCTION (SBO) DUE TO INTERNAL HERNIA BUT MIGHT BE ASSOCIATED WITH AN INCREASED RISK OF EARLY SBO TRIGGERED BY THE JEJUNOJEJUNAL ANASTOMOSIS (JJS) KINKING. THE AIM OF THIS STUDY WAS TO ASSESS HOW ENLARGING THE JJS WITH A BIDIRECTIONAL LINEAR STAPLING CAN AID IN AVOIDING THE RISK OF EARLY SBO BY KINKING. THIS RETROSPECTIVE COHORT STUDY CONCERNS 1327 PATIENTS WHO UNDERWENT RYGB WITH CMD BETWEEN MAY 2007 AND AUGUST 2016. THE FIRST 626 PATIENTS (GROUP A; 85 MALE AND 541 FEMALE PATIENTS; AGE RANGE: 18 TO 65 YEARS OLD; BMI: 29.98 TO 73.14) HAD A UNIDIRECTIONAL JJS. THE FOLLOWING 701 PATIENTS (GROUP B; 122 MALE AND 579 FEMALE PATIENTS; AGE RANGE: 19 TO 72 YEARS OLD; BMI: 31.99 TO 73.68) HAD A BIDIRECTIONAL SIDE-TO-SIDE JJS AND A HAND-SEWN CLOSURE OF THE REMAINING DEFECT. DURING THE SURGICAL PROCEDURE IN ALL GROUPS, A DIVISION OF THE STOMACH IS FIRST ACHIEVED HORIZONTALLY USING AN ECHELON ENDOPATH 45-MM REGULAR LINEAR STAPLER (ETHICON), BLUE CARTRIDGE, FOLLOWED BY THE USE OF TWO 45-MM LINEAR STAPLERS, BLUE CARTRIDGE IN A VERTICAL DIRECTION TO REACH THE ANGLE OF HIS. THE GASTROJEJUNOSTOMY IS CLOSED WITH THE AID OF A BACK-AND-FORTH ABSORBABLE BARBED RUNNING SUTURE CLOSING THE REMAINING DEFECT. ONE OF WHICH IS THE STRATAFIX (ETHICON). IN BOTH GROUPS, REPORTED COMPLICATIONS INCLUDED SMALL BOWEL PERFORATION (N-2), COLON PERFORATION (N-1), EARLY SMALL BOWEL OBSTRUCTION DUE TO KINKING OF THE JEJUNOJEJUNAL ANASTOMOSIS (N-11) IN WHICH THE PATIENTS WERE RE-OPERATED (3 BY OPEN SURGERY AND 8 LAPAROSCOPICALLY), LEAKAGE (N-11), INTERNAL HERNIA (N-3), UMBILICAL HERNIA (N-1), BLEEDINGS (N-15) WHICH REQUIRED TREATMENT IN THE AID OF INTRAVENOUS PROTON PUMP INHIBITORS AND THE THROMBOPROPHYLAXIS INJECTIONS WERE INTERRUPTED AND 1 PATIENT NEEDED AN EARLY RE-OPERATION, SUB-PHRENIC ABSCESS (N-2), AND ABDOMINAL PAIN (N-18) WITHOUT COMPLICATION, TREATED MEDICALLY BUT HOSPITALIZED. THE RESULTS SHOWED THAT BIDIRECTIONAL LINEAR STAPLING OF THE JEJUNOJEJUNOSTOMY SIGNIFICANTLY DECREASES THE RISK OF BOWEL OBSTRUCTION DUE TO THE KINKING OF THE ANASTOMOSIS. THE ENLARGEMENT OF THE JEJUNOJEJUNAL ANASTOMOSIS IN THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS TECHNIQUE IS ASSOCIATED WITH A REDUCED RISK OF EARLY SMALL BOWEL OBSTRUCTIONS DUE TO THE JEJUNOJEJUNOSTOMY KINKING. THIS BIDIRECTIONAL STAPLING CAN BE APPLIED WITHOUT ADDING ANY SURGICAL DIFFICULTY OR SEVERE COMPLICATIONS AND ALSO WITHOUT MITIGATING THE GASTRIC BYPASS EFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483533 STRATAFIX UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention