BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7327369 · Received March 9, 2018

    Report

    Report Number
    2210968-2018-71377
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    February 28, 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). DATE SENT TO FDA: 3/09/2018. (B)(4). NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE SPECIFY THE NUMBER OF PATIENTS IN THE STUDY WHO DEVELOPED EARLY POSTOPERATIVE GRADE 1 TO 2 COMPLICATIONS OF URINARY TRACT INFECTIONS AS THE NUMBER COMPRISED WITH THE COMBINATION OF CASES WHO HAD HIGH RESIDUALS (REPORTED WITH 7 PATIENTS IN LRT AND 12 PATIENTS IN ART). 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 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 USED IN THIS PROCEDURE? 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. (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE: LAPAROSCOPIC RADICAL TRACHELECTOMY IS AN ALTERNATIVE TO LAPAROTOMY WITH IMPROVED PERIOPERATIVE OUTCOMES IN PATIENTS WITH EARLY-STAGE CERVICAL CANCER . AUTHOR(S): ALI KUCUKMETIN, MD, IOANNIS BILIATIS, MD, NITHYA RATNAVELU, MD, AMIT PATEL, MD, IAIN CAMERON, MD, ANGELA RALTE, MD, AND RAJ NAIK, MD . CITATION: INT J GYNECOL CANCER 2014;24: 135-140; DOI: 10.1097/IGC.0000000000000031. THE STUDY AIMED TO EVALUATE THE 2 PROCEDURES OF ABDOMINAL RADICAL TRACHELECTOMY (ART) AND LAPAROSCOPIC RADICAL TRACHELECTOMY (LRT) AND COMPARE THE SURGICOPATHOLOGIC AND PERIOPERATIVE OUTCOMES. TWENTY SEVEN FEMALE PATIENTS WITH EARLY STAGE OF CERVICAL CANCER (STAGE IB1 DISEASE) UNDERWENT RADICAL TRACEHLECTOMY: N=16 ART (MEDIAN AGE OF 26 YEARS) AND N=11 LRT (MEDIAN AGE OF 28 YEARS). ALL PROCEDURES WERE CARRIED OUT USING HARMONIC SCALPEL. IF THE PROXIMAL SECTION IS FREE OF TUMOR AFTER THE EXCISE OF THE TRACHELECTOMY SPECIMEN, THE OPERATION RESUMED WITH THE PLACEMENT OF THE CERVICAL SUTURE (1.0 ETHIBOND) TO PREVENT FUTURE PREMATURE DELIVERY. UTEROVAGINAL ANASTOMOSES WAS ACHIEVED USING VICRYL CONTINUOUS SUTURE. EARLY POSTOPERATIVE COMPLICATIONS INCLUDED URINARY TRACT INFECTION AND HIGH RESIDUALS AFTER REMOVAL OF CATHETER (N=7 LRT GROUP, AND N=12 ART GROUP). LATE COMPLICATIONS INCLUDED UTEROVAGINAL FISTULA (N=1) THAT REQUIRED SURGICAL INTERVENTION, AND RECURRENT VAGINAL INFECTION AND EROSION OF VAGINAL WALL (N=1) BECAUSE OF CERVICAL SUTURE WHICH REQUIRED REMOVAL. THE STUDY SHOWED THAT THE LRT CAN BE CONSIDERED AS AN ALTERNATIVE TO OPEN PROCEDURE, WITH ADVANTAGES INCLUDING REDUCED BLOOD LOSS AND REDUCED LENGTH OF HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169950 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention