BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7667973 · Received July 6, 2018

    Report

    Report Number
    2210968-2018-74158
    Event Type
    Injury
    Date Received
    July 6, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE EXPLAIN DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? IF YES, PLEASE EXPLAIN HAS THE COMPLAINT BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT NUMBER. CITATION: MED SCI MONIT. 2016; 22: 540-548. DOI: 10.12659/MSM.896853. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : SHEN¿S WHOLE-LAYER TIGHTLY APPRESSED ANASTOMOSIS TECHNIQUE FOR DUCT-TO- MUCOSA PANCREATICOJEJUNOSTOMY IN PANCREATICODUODENECTOMY. AUTHOR : TIAN ZHANG, XINJING WANG, ZHEN HUO , YUAN SHI , JIABIN JIN , QIAN ZHAN , HAO CHEN XIAXING DENG , BAIYONG SHEN. CITATION: MED SCI MONIT. 2016; 22: 540-548. DOI: 10.12659/MSM.896853. THE OBJECTIVES OF THE STUDY WAS TO PROVIDE A NOVEL ANASTOMOTIC METHOD FOR OPERATIONS INVOLVING THE CHILD TECHNIQUE, TERMED THE ¿WHOLE-LAYER TIGHTLY APPRESSED ANASTOMOSIS TECHNIQUE¿. AN IMPROVED PANCREATIC WHOLE-LAYER SUTURE TECHNIQUE WAS USED WHEN THE AUTHORS PERFORMED THE DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMIES. THIS NEW METHOD WAS USED IN 41 PATIENTS (STUDY GROUP; 26 MALE 15 FEMALE PATIENTS; MEAN AGE: 57.90 ± 14.32; BMI: 22.43 ± 3.07) AND WAS COMPARED WITH THE TRADITIONAL DUCT-TO-MUCOSA ANASTOMOSIS TECHNIQUE THAT WAS USED IN 50 PATIENTS (CONTROL GROUP; 36 MALE 14 FEMALE PATIENTS; MEAN AGE: 58.12 ± 11.60; BMI: 23.68 ± 5.76). DURING THE SURGICAL PROCEDURE IN ALL GROUPS, THE OUTER-LAYER SUTURING WAS PERFORMED WITH DOUBLE-NEEDLE PROLENE 3-0 CONTINUOUS SUTURING OF THE PANCREATIC PARENCHYMA AND THE SEROMUSCULAR LAYER OF THE JEJUNUM. THE INTESTINAL MARGINS AND PANCREATIC MARGINS WERE 1 CM, AND THE NEEDLE SPACING WAS APPROXIMATELY 0.5 CM. NEXT, THE AUTHOR¿S TIED THE PROLENE SUTURES WITH RELATIVELY LOW TENSION. IN THE STUDY GROUP, OPPOSING TO THE PANCREATIC DUCT, AN ENTEROTOMY WAS MADE AT THE JEJUNUM (O-RING) VIA ELECTROCAUTERY. THE AUTHORS TIGHTENED THE NEEDLE AND FINISHED 1 SUTURE. FIVE INTERRUPTED PROLENE 5-0 SUTURES WERE PLACED; 1 SUTURE IN THE MIDDLE AND 2 ON EACH SIDE. THE INNER LAYER AND OUTER LAYERS WERE COMPLETED WITH THE SAME METHOD DESCRIBED PREVIOUSLY. THE INNER LAYER WAS COMPLETED WITH 4 OR 5 PROLENE 5-0 INTERRUPTED SUTURES. IN THE CONTROL GROUP, THE POSTERIOR OUTER ROW OF PROLENE 3-0 SUTURES WAS PLACED AS DESCRIBED PREVIOUSLY. THE AUTHORS HELD THE SUTURES WITH TENSION, AND THE PANCREATIC DUCT WAS THEN IDENTIFIED. A SMALL, FULL-THICKNESS JEJUNOTOMY WAS THEN CREATED VIA ELECTROCAUTERY OPPOSITE THE PANCREATIC DUCT. THE POSTERIOR INNER LAYER WAS THEN CREATED USING PROLENE 6-0 SUTURES. IN THE STUDY GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE PANCREATIC FISTULA (N-6), ASCITES (N-2), TRANSIENT INTRA-ABDOMINAL HEMORRHAGE ON POST-OPERATIVE DAY 7 (N-1) AND WAS RECOVERED THROUGH NPO, A CONTINUED SOMATOSTATIN INJECTION PUMP, PARENTERAL NUTRITION, AND OTHER SYMPTOMATIC TREATMENTS, WOUND INFECTION (N-1), AND ABDOMINAL INFECTION (N-2). IN THE CONTROL GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE PANCREATIC FISTULA (N-20), ASCITES (N-3), INTRA-ABDOMINAL HEMORRHAGE AND UNCONTROLLED HEMORRHAGIC SHOCK (N-1) WHICH REQUIRED RE-OPERATION, BILIARY FISTULA (N-3), WOUND INFECTION (N-2), AND ABDOMINAL INFECTION (N-4). IT WAS CONCLUDED THAT THE WHOLE-LAYER SUTURING TECHNIQUE FOR DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY IN PANCREATICODUODENECTOMY EFFECTIVELY REDUCES THE RATE OF POPF AFTER PD. THIS METHOD IS SAFER, MORE RELIABLE, AND MORE FAVORABLE THAN THE TRADITIONAL DUCT-TO-MUCOSA TECHNIQUE AND PROVIDES BETTER SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510251 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention