BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7692271 · Received July 16, 2018

    Report

    Report Number
    2210968-2018-74411
    Event Type
    Injury
    Date Received
    July 16, 2018
    Report Date
    June 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PRODUCT (SILK OR VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: ANN HEPATOBILIARY PANCREAT SURG. 2017; 21: 39-47. DOI: HTTPS://DOI.ORG/10.14701/AHBPS.2017.21.1.39. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: AN INTUITIVE METHOD OF DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY AFTER PANCREATICODUODENECTOMY: USE OF ONE-STEP CIRCUMFERENTIAL INTERRUPTED SUTURES AUTHORS: MOONWHAN KIM, WOO YOUNG SHIN, KEON-YOUNG LEE, AND SEUNG-IK AHN CITATION: ANN HEPATOBILIARY PANCREAT SURG. 2017; 21: 39-47. DOI: HTTPS://DOI.ORG/10.14701/AHBPS.2017.21.1.39. IN THIS STUDY, THE AUTHORS INTRODUCED A SLIGHT MODIFICATION OF THE CATTELL-WARREN PANCREATICOJEJUNOSTOMY (PJ) TECHNIQUE WHICH RESOLVES THE INSUFFICIENT SPACE PROBLEM AS THE WHOLE DUCT CIRCUMFERENCE IS COMPLETED IN 1 STEP COMPARED TO THE COMMONLY PRACTICED ¿POSTERIOR-FIRST¿ TECHNIQUE. THE AUTHORS BELIEVED THAT THE METHOD IS INTUITIVE AND CAN BE PERFORMED BY BEGINNERS. FROM JUNE 2003 TO MAY 2016, A TOTAL OF 151 PATIENTS (91 MALE AND 60 FEMALE PATIENTS; AGE RANGE: 32 TO 81 YEARS OLD) UNDERWENT PD WITH THE MODIFIED PJ METHOD. DURING THE DUCT-TO-MUCOSA ANASTOMOSIS, THE JEJUNUM AND THE PANCREATIC STUMP ARE LOCATED SUCH THAT THEY FACE EACH OTHER, LEAVING SUFFICIENT SPACE FOR THE NEEDLE WORK. TWO VICRYL 4-0 SUTURES ARE PERFORMED AT THE INFERIOR AND SUPERIOR EDGES OF THE PANCREATIC DUCT, AND FIXED IN SITU WITH SMALL HEMOSTATIC CLAMPS. AN OUT-IN-IN-OUT NEEDLE MOVEMENT STARTING FROM THE JEJUNAL SIDE IS RECOMMENDED TO ENSURE ACCURATE PANCREATIC DUCT PUNCTURE. SUTURING OF THE POSTERIOR SEMICIRCLE OF DUCT-TO-MUCOSA ANASTOMOSIS IS STARTED AT THE CENTER, AND THEN TO THE EITHER SIDE. SUTURE MATERIALS ARE GENTLY TIGHTENED DURING THE APPROXIMATION TO PREVENT DOG-EAR FORMATION. KNOT TYING STARTS AT THE SUPERIOR AND INFERIOR SUTURES. THE OUTER SEROMUSCULAR LAYER IS SUTURED WITH NON-ABSORBABLE SUTURE MATERIAL MERSILK 3-0 BLACK SILK SUTURE. AN INTERRUPTED SIMPLE SUTURE IS STARTED AT THE INFERIOR AND SUPERIOR BORDERS OF THE PJ. THE NEEDLE SHOULD ENTER FROM PANCREATIC PARENCHYMA AND IT SHOULD BE PERPENDICULAR TO THE PANCREATIC SURFACE WITH A ROUNDING MOTION COMPATIBLE WITH THE NEEDLE¿S CURVATURE. SUTURING OF THE ANTERIOR ROW OF THE SEROMUSCULAR LAYER IS STRAIGHTFORWARD. THE ENTIRE PJ ANASTOMOSIS IS NOW COMPLETE. REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE PANCREATIC FISTULA (POPF) GRADE A (N-27; 17.9%), POPF GRADE B (N-23; 15.2%), POPF GRADE C (N-6; 4.0%), POST-OPERATIVE BLEEDING (N-1), AND POST-OPERATIVE BLEEDING LEADING TO DEATH (N-6). IN CONCLUSION, THE AUTHORS PROPOSED A MODIFIED PJ METHOD THAT IS STRAIGHTFORWARD. THE TECHNIQUE IS ESPECIALLY USEFUL IN CASES WITH A SMALL PANCREATIC DUCT. THE OPERATIVE RESULTS OF THE PJ METHOD HAVE REMAINED FAIRLY STABLE, AND THAT BOTH HEPATO-BILIARY-PANCREATIC SURGERY SPECIALISTS AND BEGINNER SURGEONS WHO ENCOUNTER UNAVOIDABLE PD AS IN CASES OF PANCREATIC HEAD TRAUMA, WILL FIND THIS TECHNIQUE USEFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534689 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention