BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18837539 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02387
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    November 6, 2021
    Report Date
    March 5, 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
    US
    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. CITATIONS : ANN VASC SURG. VOL 80.130-135. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.08.047.

    Description of Event or Problem · 0

    TITLE : SINGLE-INSTITUTION LEARNING CURVE FOR MANAGEMENT OF MEGA-FISTULAE REVISION. THE AIM OF THIS STUDY WAS TO DESCRIBE OUR EARLY EXPERIENCE WITH A TECHNIQUE OF COMPLETE MEGA-FISTULA RESECTION AND REPLACEMENT WITH AN EARLY USE PROSTHETIC GRAFT THAT BOTH MAINTAINS EXISTING AV ACCESS AND ELIMINATES THE NEED FOR LONG-TERM CATHETER (LTC) PLACEMENT; INCLUDING LESSONS LEARNED. A RETROSPECTIVE REVIEW OF MEDICAL RECORDS WAS CONDUCTED FROM (B)(6) 2021. THE PATIENTS WERE DIVIDED INTO TWO GRAFTS ; PROPATEN (N=4) AND ACUSEAL (N=4). BOTH ANASTOMOSES ARE SEWN IN AN END-TO-END FASHION USING CONTINUOUS 6-0 PROLENE SUTURES. THE REPORTED COMPLICATIONS INCLUDED SKIN NECROSIS (N=1), SEROMA (N=1), HEMATOMA (N=1), CENTRAL NERVOUS OCCLUSION (N=1) AND GRAFT INFECTION (N=1). IN CONCLUSION, COMPLETE MEGA-FISTULA RESECTION AND REPLACEMENT WITH ACUSEAL GRAFT MAINTAINS EXISTING AV ACCESS AND MAY ELIMINATE THE NEED FOR LONG-TERM CATHETER PLACEMENT. OUR EARLY EXPERIENCE WITH THIS TECHNIQUE IS ENCOURAGING, BUT FURTHER FOLLOW UP IS REQUIRED TO DETERMINE THE DURABILITY OF THIS APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166693 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention