BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE BLU 75CM 3-0 KS

    MDR report key: 18646701 · Received February 5, 2024

    Report

    Report Number
    2210968-2024-00965
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    December 15, 2020
    Report Date
    February 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. CITATION: CLIO. EXP. OBSTET. GYNECOL. - ISSN: 0390-6663 XLVII, N. 6, 2020, HTTPS://DOI.ORG/10.31083/J.CEOG.2020.06.5517.

    Description of Event or Problem · 0

    TITLE: VAGINAL ASSISTED LAPAROSCOPIC SACROCERVICOPEXY WITH ANTERIOR COLPOTOMY (VALSAC): TECHNIQUE AND MEAN 20 MONTHS OUTCOMES. THE MAIN PURPOSE OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF VAGINAL-ASSISTED LAPAROSCOPIC SACROCERVICOPEXY WITH ANTERIOR COLPOTOMY (VALSAC) FOR APICAL PELVIC ORGAN PROLAPSE TO REDUCE MESH EROSION AND EXPOSURE. BETWEEN APRIL 2017 AND JUNE 2019, 23 WOMEN WITH STAGE III AND IV PROLAPSE TREATED WITH VAGINAL-ASSISTED LAPAROSCOPIC SACROCERVICOPEXY WITH ANTERIOR COLPOTOMY (VALSAC) WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 59.35 ± 9 (RANGE, 43 - 74) YEARS AND THE MEAN BMI WAS 28.78 ± 3.17 (RANGE 24.6- 34.4) KG/M2. DURING THE PROCEDURE, THE ROUND LIGAMENT WAS OCCLUDED AND CUT USING AN ULTRASONIC SCALPEL (ETHICON ENDO-SURGERY). THE UTEROVESICAL FOLD OF THE PERITONEUM WAS ALSO DISSECTED USING THE ULTRASONIC SCALPEL (ETHICON ENDO-SURGERY) TO ALLOW IDENTIFICATION OF THE VESICOCERVICAL SPACE AND THE MOBILIZATION OF THE PERITONEUM OF THE BLADDER. OCCLUSION OF BOTH THE INFUNDIBULOPELVIC LIGAMENTS AND UTERINE ARTERIES WERE PERFORMED USING A COMPETITOR BIPOLAR LIGASURE SYSTEM (MANUFACTURER: COVIDIEN). THE 0 PROLENE SUTURE, MODEL W8630 (ETHICON) WAS USED TO ATTACH THE PARTS THE OF NON-ETHICON Y-MESH (MANUFACTURER: UNKNOWN) TO THE FRONT OF THE CERVIX, THE MIDLINE OF THE POSTERIOR CERVIX AND TO THE ANTERIOR LONGITUDINAL LIGAMENT OF THE SACRAL PROMONTORY. REPORTED COMPLICATIONS INCLUDED RECURRENT PROLAPSE DUE TO SEPARATION OF THE Y-MESH THAT HAD BEEN ATTACHED TO THE ANTERIOR LONGITUDINAL LIGAMENT OF THE SACRAL PROMONTORY USING THE 0 PROLENE SUTURE IN CASE NO. 7 (N=1) AND NEW URINARY INCONTINENCE (N=2). IN CONCLUSION, WE PROPOSE THAT VALSAC IS A PROMISING, MINIMALLY INVASIVE TECHNIQUE FOR PELVIC FLOOR RECONSTRUCTION THAT APPEARS TO PROVIDE GOOD OUTCOMES. THIS SMALL SERIES SHOWED LOW EXPOSURE RATES AND BLOOD LOSS, SHORT OPERATIVE TIMES AND A LOW RATE OF SYMPTOMATIC PELVIC ORGAN PROLAPSE RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091224 PROLENE BLU 75CM 3-0 KS SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention LIGASURE SYSTEM: COVIDIEN