BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9975000 · Received April 17, 2020

    Report

    Report Number
    2210968-2020-03194
    Event Type
    Injury
    Date Received
    April 17, 2020
    Report Date
    March 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/29/2020. CORRECTED INFORMATION: B1, B2, H1 ¿ IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED AND THE FOLLOWING WAS OBTAINED: 1. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? - WE CONSIDER THAT COMPLICATIONS FOUND AND REPORTED IN THIS STUDY WERE NOT ASSOCIATED TO THE SUTURE CHARACTERISTICS. 2. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? - NO, AUTHORS DID NOT DISCUSS COMPLICATIONS WITH ETHICON. 3. PATIENT DEMOGRAPHICS, THEY ARE REPORTED IN TABLE 1. 4. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBE IN THE ARTICLE? - NO, IT COULD BE ATTRIBUTED TO DIFFERENT CAUSES.

    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. 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL 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 (VICRYL SUTURE) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER OF THE ETHICON DEVICES USED. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2018) 00, 1-6; 2018; DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2018.08.030. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BARBED SUTURE VERSUS CONVENTIONAL SUTURE FOR VAGINAL CUFF CLOSURE IN TOTAL LAPAROSCOPIC HYSTERECTOMY: RANDOMIZED CONTROLLED CLINICAL TRIAL". AUTHORS: CLAUDIA C. LOPEZ, MD; JOSE F. DE LOS RIOS, MD; YENYFFER GONZALEZ, MD, ELSA MARIA VASQUEZ-TRESPALACIOS, MSCM, DANIEL SERNA, MD; ADRIANA ARANGO, MD; CAROLINA CIFUENTES, MD; RICARDO VASQUEZ, MD; JUAN D. CASTANEDA, MD; LUIS A. ALMANZA, MD, AND LUIS A. JIMENEZ, MD. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2018) 00, 1-6; 2018; DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2018.08.030. THE AIMED OF THIS RANDOMIZED, CONTROLLED CLINICAL TRIAL TO DETERMINE THE SURGICAL TIME, SUTURE TIME, PRESENCE OF POSTOPERATIVE DYSPAREUNIA, AND COMPLICATIONS THAT OCCUR AFTER CLOSING THE VAGINAL CUFF WITH A BARBED SUTURE COMPARED WITH CONVENTIONAL SUTURE. BETWEEN FEBRUARY AND APRIL 2016, 150 PATIENTS WERE INCLUDED IN THE STUDY. SEVENTY-FIVE PATIENTS (MEAN AGE=43.16 YEARS; MEAN BMI=27.17 KG.M^2) WERE RANDOMIZED FOR VAGINAL CUFF CLOSURE WITH BARBED SUTURE AND 75 PATIENTS (MEAN AGE=43.01 YEARS; MEAN BMI=26.40 KG/M^2) FOR CLOSURE WITH POLYGLACTIN 910. THE PATIENTS UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY WITH CLOSURE OF THE VAGINAL CUFF BY INTRACORPOREAL SUTURE USING BARBED SUTURE OR POLYGLACTIN 910 (COATED VICRYL SUTURE; ETHICON). REPORTED COMPLICATIONS INCLUDED BLEEDING (N=7); PAIN (N=10); FEVER (N=4); VAGINAL CUFF CELLULITIS (N=4) WHICH ALL WERE MANAGED WITH IN-HOSPITAL ANTIBIOTICS FOR 48 HOURS AND THEN AMBULATORY ORAL TREATMENT, WITH ALL CASES RESOLVED; CUFF ABSCESS (N=1) REQUIRED HOSPITALIZATION WITH ANTIBIOTIC PARENTERAL THERAPY, AND HAD RESOLUTION CONFIRMED BY ULTRASOUND; CUFF DEHISCENCE (N=1) WHICH THE PATIENT UNDERWENT VAGINAL CUFF CLOSURE UNDER GENERAL ANESTHESIA WITH ADEQUATE RESOLUTION AND AMBULATORY MANAGEMENT; DEEP DYSPAREUNIA (N=12). IN CONCLUSION, THE CURRENT STUDY FINDINGS CONCLUDE THAT THE USE OF BARBED SUTURE IN TOTAL LAPAROSCOPIC HYSTERECTOMY FOR BENIGN PATHOLOGY DOES NOT SHOW ADVANTAGES IN THE SURGICAL TIME OF CUFF CLOSURE OR INCIDENCE OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436353 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention