BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18817568 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02198
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    September 4, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF CLINICAL MEDICINE, (2023); 14 (10): 1-12. HTTPS://DOI.ORG/10.3390/JCM12175765.

    Description of Event or Problem · 0

    TITLE: PARACOLIC GUTTER ROUTING: A NOVEL RETROPERITONEAL EXTRA-ANATOMICAL REPAIR FOR INFECTED AORTO-ILIAC AXIS. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DESCRIBE AND ANALYZE OUTCOMES OF A NOVEL EXTRA-ANATOMICAL PARACOLIC GUTTER ROUTING TECHNIQUE FOR SURGICAL REPAIR OF AORTO-ILIAC INFECTIONS. BETWEEN MAY 2015 AND DECEMBER 2022, A TOTAL OF 6 PATIENTS (3 MALES AND 3 FEMALES WITH MEAN AGE OF 69 ± 12 YEARS) WITH AORTO-ILIAC INFECTIONS WERE TREATED WITH THE PARACOLIC GUTTER ROUTING TECHNIQUE. THIS STUDY WAS TREATED WITH 4-0 PROLENE SUTURE. ALL PROCEDURES WERE TECHNICAL SUCCESSES AND THERE WERE NO MAJOR INTRAOPERATIVE OR EARLY POSTOPERATIVE COMPLICATIONS. NO INTRAOPERATIVE DEATHS OCCURRED. THE MEMAN FOLLOW-UP PERIOD WAS 52 ± 44 MONTHS. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: 4-0 PROLENE SUTURE. (N=1) GRAFT THROMBOSIS. TREATMENT: THROMBECTOMY. IN CONCLUSIONS, CREATION OF A NEO-AORTOFEMORAL SYSTEM USING THE RETRO-PERITONEAL PARACOLIC GUTTER IS A SAFE APPROACH IN A HETEROGENEOUS COHORT OF PATIENTS WITH AORTO-ILIAC GRAFT INFECTIONS AND PRESENTS AN ALTERNATIVE TO OTHER METHODS THAT CAN BE ASSOCIATED WITH A HIGH RISK OF RE-INFECTION. LONG-TERM FOLLOW-UP WITH IMAGING AND TO ENSURE MEDICATION COMPLIANCE IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919814 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention