BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7643803 · Received June 27, 2018

    Report

    Report Number
    2210968-2018-73898
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    June 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 USED IN THIS PROCEDURE? CITATION: SURG ENDOSC (2016) 30:2367¿2373.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PRIMARY NON-CLOSURE OF MESENTERIC DEFECTS IN LAPAROSCOPIC ROUXEN-Y GASTRIC BYPASS: REOPERATIONS AND INTRAOPERATIVE FINDINGS IN 146 PATIENTS. AUTHORS: TARIK DELKO, MARKO KRALJEVIC, THOMAS KO¨STLER, LINCOLN ROTHWELL, RAOUL DROESER, SILKE POTTHAST, DANIEL OERTLI, AND URS ZINGG. CITATION: SURG ENDOSC (2016) 30:2367¿2373; DOI 10.1007/S00464-015-4486-1; PUBLISHED ONLINE: 3 SEPTEMBER 2015. THE AIM OF THIS STUDY WAS TO ANALYZE CLINICAL, IMAGING AND INTRAOPERATIVE FINDINGS IN PATIENTS THAT UNDERWENT ELECTIVE OR ACUTE SURGICAL CLOSURE OF MESENTERIC DEFECTS FOLLOWING PRIMARY LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB). BETWEEN THE PERIODS OF 2000 TO 2003, A TOTAL OF 585 LAPAROSCOPIC RYGB WERE PERFORMED, 269 PATIENTS WITH NON-CLOSURE OF MESENTERIC DEFECTS AND 316 WITH PRIMARY CLOSURE OF MESENTERIC DEFECTS (77 WITH VVLL-LRYGB AND 239 WITH PROXIMAL LRYGB) WERE IDENTIFIED. ONE HUNDRED AND FORTY-SIX PATIENTS (59.3 %) WITH OPEN MESENTERIC DEFECTS HAD REOPERATIONS AND REPRESENTED THE MAIN COHORT FOR ANALYSIS. ONE HUNDRED AND ONE PATIENTS (37.5 %) DID NOT UNDERGO ANY FURTHER REOPERATIONS AND WERE NOT FURTHER ANALYZED. THE STANDARD TECHNIQUE OF THE AUTHORS UNTIL NOVEMBER 2008 CONSISTED OF A VERY, VERY LONG LIMB LRYGB (VVLLLRYGB). ONE PATIENT DIED PRIOR TO 2008 OF ISCHEMIC BOWEL AND ASSOCIATED SEPSIS DUE TO A STRANGULATED MESO-JEJUNAL HERNIA. FROM NOVEMBER 2008 ONWARDS, THE BILIO-PANCREATIC LIMB WAS ORIENTATED FROM THE LEFT AND MESENTERIC DEFECTS WERE ROUTINELY CLOSED WITH NON-ABSORBABLE INTERRUPTED SUTURES (PROLENE 3-0) FOLLOWING LRYGB. OUR EXPERIENCE WITH NON-CLOSURE LED TO THE MODIFICATION OF OUR SURGICAL TECHNIQUE AND CLOSURE OF ALL POTENTIAL DEFECTS WITH NON-ABSORBABLE (PROLENE 3-0) INTERRUPTED SUTURES. PATIENTS WHO PRESENT WITH ABDOMINAL PAIN AFTER LRYGB WITH OPEN MESENTERIC DEFECTS ARE PLANNED FOR DIAGNOSTIC LAPAROSCOPY. IN CASE OF OPEN DEFECTS, CLOSURE IS PERFORMED USING NON-ABSORBABLE INTERRUPTED SUTURE. EARLY SURGICAL MORBIDITY (3 %) CONSISTED OF 1 CYSTIC STUMP LEAK AFTER CONCOMITANT CHOLECYSTECTOMY, 1 WOUND INFECTION AND 3 SMALL BOWEL OBSTRUCTION (SBO)¿S DUE TO KINKING AT THE ENTERO-ENTEROSTOMY. IN CONCLUSION, THE SPONTANEOUS CLOSURE RATE OF MESENTERIC DEFECTS DUE TO POST-OPERATIVE INFLAMMATION OR ADHESIONS IS VERY LOW LEAVING A LIFE-LONG RISK FOR IH. WITHOUT CLOSURE OF MESENTERIC DEFECTS THE INCIDENCE OF IH IS UNACCEPTABLY HIGH, AND THUS THE CLOSURE OF THE MESENTERIC DEFECTS AT TIME OF PRIMARY LRYGB IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486396 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention