BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18791622 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-02013
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 4, 2021
    Report Date
    February 27, 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. CITATION: THORAC CARDIOVASC SURG 2022;70:645¿651. DOI HTTPS://DOI.ORG/10.1055/S-0041-1723000. RELATED EVENTS CAPTURED VIA 2210968-2024-02010, 2210968-2024-02011, 2210968-2024-02012, 2210968-2024-02014.

    Description of Event or Problem · 0

    TITLE: OVINE BIOSYNTHETIC GRAFTS FOR AORTOILIAC RECONSTRUCTIONS IN NONSTERILE OPERATIVE FIELDS. THIS RESTROPECTIVE STUDY AIMS TO REPORT THE AUTHORS' EXPERIENCE TO DATE WITH THE OMNIFLOW II VASCULAR PROSTHESES (LEMAITRE VASCULAR, INC.). BETWEEN (B)(6) 2015 AND (B)(6) 2019, A TOTAL OF 16 PATIENTS (10 MALE AND 6 FEMALE; MEAN AGE WAS 65.5±5.65 YEARS) WHO RECEIVED THE OMNIFLOW II PROSTHESES AS AORTOBIFEMORAL OR AORTO-BI-ILIAC GRAFTS WERE INCLUDED IN THE STUDY. IN GENERAL, OMNIFLOW II PROSTHESES WERE USED IN PATIENTS WHO WERE CONSIDERED AT A HIGH RISK OF GRAFT INFECTION OWING TO THE NEED FOR SIMULTANEOUS SURGERY ON ABDOMINAL ORGANS OR IN VIEW OF THE PRESENCE OF GANGRENE IN THE EXTREMITIES (PREVENTION GROUP, N=9), OR TO REPLACE ACTIVELY INFECTED PROSTHETIC VASCULAR GRAFTS (TREATMENT GROUP, N=7). OMNIFLOW II GRAFT ANASTOMOSES WERE PERFORMED IN AN END-TO-SIDE FASHION IN CASES OF PERIPHERAL ARTERY DISEASE, AND IN AN END-TO-END FASHION IN ANEURYSMAL AORTAS USING 4¿0 PROLENE RUNNING SUTURES (FIG. 2). REPORTED COMPLICATIONS INCLUDE THE FOLLOWING: A 67-YEAR-OLD FEMALE PATIENT (N=1) - GRAFT INFECTION. - URETEROILIAC FISTULA. TREATMENT: STENT IMPLANTATION INTO THE PROSTHESIS TO TREAT URETEROILIAC FISTULA. IN CONCLUSION, USING BIFURCATED OMNIFLOW II VASCULAR PROSTHESES IN PATIENTS WITH OR AT A HIGH RISK OF VASCULAR GRAFT INFECTION IS ADVISABLE, AND IS ASSOCIATED WITH ACCEPTABLE REINFECTION AND PATENCY RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628441 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention