BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7404050 · Received April 6, 2018

    Report

    Report Number
    2210968-2018-71986
    Event Type
    Injury
    Date Received
    April 6, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 ANY DEFICIENCY OF THE ETHICON PRODUCT PDS SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: JOURNAL OF SURGICAL RESEARCH 196 (2015) 107-112; HTTP://DX.DOI.ORG/10.1016/J.JSS.2015.02.059. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: ISOPERISTALTIC VERSUS ANTIPERISTALTIC STAPLED SIDE-TO-SIDE ANASTOMOSIS FOR COLON CANCER SURGERY: A RANDOMIZED CONTROLLED TRIAL AUTHOR(S): AKIHISA MATSUDA, MD, MASAO MIYASHITA, MD, SATOSHI MATSUMOTO, MD,A NOBUYUKI SAKURAZAWA, MD, GORO TAKAHASHI, MD MARINA YAMADA, PHD AND EIJI UCHIDA, MD CITATION: JOURNAL OF SURGICAL RESEARCH 196 (2015) 107-112; HTTP://DX.DOI.ORG/10.1016/J.JSS.2015.02.059. THE AIM OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO EVALUATE WHETHER ISOPERISTALTIC STAPLED SIDE-TO-SIDE ANASTOMOSIS IS COMPARABLE WITH ANTIPERISTALTIC SSSA FOR COLON CANCER SURGERY IN TERMS OF SHORT TERM OUTCOMES. BETWEEN JUL2012 AND JAN2014, 40 PATIENTS WITH COLON CANCER WHO UNDERWENT ELECTIVE CURATIVE RESECTION AND HAD ENOUGH MOBILITY AT ANASTOMOSIS WERE RANDOMIZED INTO TWO GROUPS: ISOPERISTALTIC SSSA GROUP (N=20; N=11 MALE AND N=9 FEMALE; AGE OF 66±12 YEARS) AND ANTIPERISTALTIC SSSA GROUP (N=20; N=11 MALE AND N=9 FEMALE; AGE OF 68±10 YEARS). A 60-MM ECHELON ENDOPATH WITH BLUE CARTRIDGE WAS UTILIZED IN RESECTION AND ANASTOMOSIS FOR BOTH GROUPS. THE ENTRY HOLE OF THE LINEAR STAPLER WAS CLOSED WITH A 1 LAYER OF RUNNING 4-0 PDS II SUTURES. THE COLONIC MESENTERIC DEFECT WAS CLOSED WITH INTERRUPTED SUTURES WITH 4-0 PDS II IN OPEN SURGERY. SURGICAL COMPLICATIONS INCLUDED WOUND INFECTION (N=1 ANTIPERISTALTIC SSSA GROUP AND N=1 ISOPERISTALTIC SSSA GROUP), PROLONGED ILEUS (N=1 ANTIPERISTALTIC SSSA GROUP AND N=2 ISOPERISTALTIC SSSA GROUP), INTRA-ABDOMINAL ABSCESS (N=1 ANTIPERISTALTIC SSSA GROUP AND N=2 ISOPERISTALTIC SSSA GROUP), ANASTOMOTIC LEAKAGE (N=2 ISOPERISTALTIC SSSA GROUP) AND ANASTOMOTIC STENOSIS (N=1 ANTIPERISTALTIC SSSA GROUP). ONE PATIENT IN THE ANTIPERISTALTIC SSSA GROUP HAD ANASTOMOTIC STENOSIS, WHICH IMPROVED CONSERVATIVELY. IN ISOPERISTALTIC SSSA GROUP, 2 PATIENTS WHO HAD INTRA-ABDOMINAL ABSCESS DUE TO ANASTOMOTIC LEAK, AND ONE PATIENT WHO HAD PROLONGED ILEUS HAD REOPERATIONS. THE PRESENT STUDY DEMONSTRATED THAT ALTHOUGH THE DIFFERENCE WAS NOT STATISTICALLY SIGNIFICANT, ANASTOMOTIC LEAKAGE OCCURRED ONLY IN THE ISOPERISTALTIC SSSA GROUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247693 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention