BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9623651 · Received January 23, 2020

    Report

    Report Number
    2210968-2020-00644
    Event Type
    Injury
    Date Received
    January 23, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 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 (PDS II 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 (PDS II SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS RESPONSE: NO FURTHER INFORMATION WILL BE PROVIDED. CITATION: J HEPATOBILIARY PANCREAT SCI (2014) 21:193¿198; DOI: 10.1002/JHBP.16. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: ISOLATED ROUX-EN-Y ANASTOMOSIS OF THE PANCREATIC STUMP IN A DUCT-TO-MUCOSA FASHION IN PATIENTS WITH DISTAL PANCREATECTOMY WITH EN-BLOC CELIAC AXIS RESECTION" AUTHORS: KEN-ICHI OKADA, MANABU KAWAI, MASAJI TANI, SEIKO HIRONO, MOTOKI MIYAZAWA, ATSUSHI SHIMIZU, YUJI KITAHATA, HIROKI YAMAUE CITATION: J HEPATOBILIARY PANCREAT SCI (2014) 21:193¿198; DOI: 10.1002/JHBP.16. THE AIM OF THIS PROSPECTIVE STUDY IS TO EVALUATE IF THE PANCREATICOJEJUNOSTOMY (PJ) PERFORMED IN A DUCT-TO-MUCOSA FASHION WOULD PROVIDE A FAVORABLE OUTCOME BY DECREASING THE BACK PRESSURE NOT ONLY IN THE MAIN PANCREATIC DUCT, BUT ALSO IN THE BRANCH DUCTS. BETWEEN APRIL 2008 AND AUGUST 2012, A TOTAL OF 26 PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TIME PERIOD OF THE TREATMENT TO ASSESS THE EFFECT OF PANCREATICOJEJUNOSTOMY (PJ) AT THE PANCREATIC STUMP: 13 PATIENTS (N=10 MALES AND N=3 FEMALES, MEAN AGE: 63 YEARS) WITH NO ANASTOMOSIS (UNTIL FEBRUARY 2011) AND 13 PATIENTS (N=7 MALES AND N=6 FEMALES, MEAN AGE: 68 YEARS) WITH ROUX-EN-Y PJ PERFORMED IN A DUCT-TO-MUCOSA FASHION (AFTER FEBRUARY 2011) WHO EXPECTED TO UNDERGO DP-CAR FOR PANCREATIC BODY/TAIL CARCINOMA WERE INCLUDED IN THE STUDY. IN THE NO ANASTOMOSIS GROUP, THE PANCREATIC PARENCHYMA WAS RESECTED BY BIPOLAR SCISSORS (ETHICON) (N = 6), AN ULTRASONIC DISSECTOR (HARMONIC FOCUS) (ETHICON) WITH MAIN PANCREATIC DUCT LIGATION (N = 1), OR WITH A STAPLER DEVICE (ECHELON 60 WITH A GOLD CARTRIDGE COMPRESSIBLE THICKNESS TO 1.8 MM) (ETHICON) (N = 6), ACCORDING TO THE STATUS OF THE PANCREATIC TRANSECTION SITE. IN THE PJ GROUP, THE ANASTOMOSIS WAS PERFORMED IN A NON-STENTED DUCT-TO-MUCOSA FASHION USING A SINGLE LAYER OF INTERRUPTED 5-0 PDS STITCHES (ETHICON). COMPLAINTS INCLUDED PANCREATIC FISTULA [GRADE A: N=1 WITH PJ, GRADE B: N=4 IN NO ANASTOMOSIS GROUP AND N=1 WITH PJ GROUP, GRADE C: N=1 IN NO ANASTOMOSIS GROUP AND N=1 WITH PJ GROUP], GASTRODUODENAL PERFORATION (N=2 IN NO ANASTOMOSIS GROUP), INTRA-ABDOMINAL ABSCESS (N=3 IN NO ANASTOMOSIS GROUP, N=1 IN PJ GROUP), GRADE C INTRA-ABDOMINAL HEMORRHAGE (N=3 IN NO ANASTOMOSIS GROUP, N=3 IN PJ GROUP). IN CONCLUSION, THE GREATEST ADVANTAGE OF ISOLATED ROUX-EN-Y ANASTOMOSIS OF THE PANCREATIC STUMP IN A DUCT-TO-MUCOSA FASHION IS TO SUPPRESS THE LEAKAGE WITH EXTREMELY HIGH AMYLASE LEVEL, WHICH COULD REDUCE THE INCIDENCE OF CLINICALLY SIGNIFICANT PANCREATIC FISTULA AFTER DP-CAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87918 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention