BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE PLUS UNKNOWN PRODUCT

    MDR report key: 9199593 · Received October 16, 2019

    Report

    Report Number
    2210968-2019-88748
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT (PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS, INCLUDING REPORT OF PATIENT DEATHS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PDS II SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: LANCET 2015; 386: 1254¿60; HTTP://DX.DOI.ORG/10.1016/S0140-6736(15)60459-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: SMALL BITES VERSUS LARGE BITES FOR CLOSURE OF ABDOMINAL. MIDLINE INCISIONS (STITCH): A DOUBLE-BLIND, MULTICENTRE, RANDOMISED CONTROLLED TRIAL" AUTHOR/S: EVA B DEERENBERG, JORIS J HARLAAR, EWOUT W STEYERBERG, HAROLD E LONT, HELENA C VAN DOORN, JOOS HEISTERKAMP, BAS PL WIJNHOVEN, WILLEM R SCHOUTEN, HUIB A CENSE, HEIN BAC STOCKMANN, FRITS J BERENDS, F PAUL HLJ DIJKHUIZEN, ROY S DWARKASING, AN P JAIRAM, GABRIELLE H VAN RAMSHORST, GERT-JAN KLEINRENSINK, JOHANNES JEEKEL, JOHAN F LANGE CITATION: LANCET 2015; 386: 1254¿60; HTTP://DX.DOI.ORG/10.1016/S0140-6736(15)60459-7. THIS PROSPECTIVE, MULTICENTRE, DOUBLE-BLIND, RANDOMISED CONTROLLED TRIAL AIMED TO COMPARE THE LARGE BITES SUTURE TECHNIQUE WITH THE SMALL BITES TECHNIQUE FOR FASCIAL CLOSURE OF MIDLINE LAPAROTOMY INCISIONS. BETWEEN OCT 20, 2009 AND MARCH 12, 2012, 560 PATIENTS WERE RANDOMLY ASSIGNED TO THE LARGE BITES GROUP (N=248, [N=139 MALE N=145 FEMALE, AGE RANGE OF 54-71 YEARS, AND BMI OF 22-27]) OR THE SMALL BITES GROUP (N=276 [N=137 MALE N=139 FEMALE, AGE RANGE OF 53-72 YEARS, AND BMI OF 22-27]). THE PRINCIPLE OF THE SMALL BITES TECHNIQUE CONSTITUTED PLACEMENT OF AT LEAST TWICE AS MANY STITCHES AS THE INCISION LENGTH IN CM WITH USP 2-0 PDS PLUS II (ETHICON) WITH A 31 MM NEEDLE. THE SUTURE TECHNIQUE WAS APPLIED WITH TISSUE BITES OF 5 MM AND INTERSUTURE SPACING OF 5 MM. IN ALL CASES THE STITCH INCORPORATED THE APONEUROSIS ONLY AND INCORPORATION OF FAT OR MUSCLE TISSUE WAS AVOIDED. THE CONVENTIONAL LARGE TISSUE BITES OR MASS CLOSURE TECHNIQUE WAS APPLIED WITH TISSUE BITES OF AT LEAST 1 CM AND INTERSUTURE SPACING OF 1 CM WITH USP 1 DOUBLE LOOP PDS PLUS II (ETHICON) WITH A 48 MM NEEDLE. COMPLAINT DURING 1 YEAR POSTOPERATIVE FOLLOW UP INCLUDED INCISIONAL HERNIA (N=57 IN THE LARGE BITES GROUP, N=35 IN THE SMALL BITES GROUP). OTHER POSTOPERATIVE COMPLAINTS ARE DEEP INCISIONAL INFECTION (N=12 IN LARGE BITES GROUP, N=8 IN SMALL BITES GROUP), AND BURST ABDOMEN (FASCIA DEHISCENCE) (N=2 IN LARGE BITES GROUP, N=4 IN SMALL BITES GROUP). THIS STUDY PRESENTED THAT THE SMALL BITES SUTURE TECHNIQUE IS MORE EFFECTIVE THAN THE TRADITIONAL LARGE BITES TECHNIQUE FOR PREVENTION OF INCISIONAL HERNIA IN MIDLINE INCISIONS AND IS NOT ASSOCIATED WITH A HIGHER RATE OF ADVERSE EVENTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990669 PDS II POLYDIOXANONE SUTURE PLUS UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention