BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20579345 · Received October 31, 2024

    Report

    Report Number
    2210968-2024-11300
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    February 2, 2024
    Report Date
    October 31, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATIONS: SURGERY TODAY.54:795¿800 HTTPS://DOI.ORG/10.1007/S00595-024-02793-2.

    Description of Event or Problem · 0

    TITLE: VENOUS RECONSTRUCTION USING A ROUND LIGAMENT-COVERED PROSTHETIC VASCULAR GRAFT IN RIGHT-LOBE LIVING-DONOR LIVER TRANSPLANTATION: A TECHNICAL REPORT. THE AIM THIS STUDY WAS TO EVALUATE THE SHORT TERM-OUTCOMES OF VENOUS RECONSTRUCTION USING A ROUND LIGAMENT-COVERED PROSTHETIC VASCULAR GRAFT AND ASSESS ITS EFFECTIVENESS IN THE PREVENTION OF PROSTHETIC VASCULAR GRAFT MIGRATION IN RIGHT-LOBE LIVING DONOR LIVER TRANSPLANTATION (LDLT).THIRTY PATIENTS UNDERWENT RECONSTRUCTION OF THE MIDDLE HEPATIC VEIN (MHV) TRIBUTARIES DURING RIGHT LOBE LDLT BETWEEN JANUARY, 2021 AND OCTOBER, 2022. THESE PATIENTS WERE DIVIDED INTO THE AUTOLOGOUS VASCULAR GRAFT GROUP (A GROUP, N=24) AND THE ROUND LIGAMENT-COVERED PROSTHETIC VASCULAR GRAFT GROUP (RP GROUP, N=6).THE MHV TRIBUTARY WAS ANASTOMOSED TO HEPARIN-BONDED EPTFE GRAFTS (PROPATEN GRAFT; W. L. GORE & ASSOCIATES, FLAGSTAF, AZ, USA) OR AUTOLOGOUS INTERPOSITION GRAFTS USING CONTINUOUS 7-0 PROLENE¿ SUTURES (ETHICON INC, SOMERVILLE, NJ, USA) TAKING CARE TO PREVENT STENOSIS. VENOUS ANASTOMOSIS WAS PERFORMED USING 5-0 CONTINUOUS PDS-II¿ SUTURES (ETHICONE INC, SOMERVILLE, NJ, USA). THE REPORTED COMPLICATIONS INCLUDED RIGHT PLEURAL EFFUSION (N=1), ATELECTASIS (N=1), AND BILE LEAKAGE (N=1). IN CONCLUSION, VENOUS RECONSTRUCTION USING ROUND LIGAMENT-COVERED PROSTHETIC VASCULAR GRAFTS IS A FEASIBLE AND SIMPLE METHOD TO PREVENT PROSTHETIC VASCULAR GRAFT MIGRATION IN RIGHT-LOBE LDLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962691 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention