BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18804136 · Received February 28, 2024

    Report

    Report Number
    2210968-2024-02119
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 15, 2023
    Report Date
    February 28, 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
    UP
    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. HTTPS://DOI.ORG/10.1016/J.AVSURG.2023.100167.

    Description of Event or Problem · 0

    TITLE : HYBRID MANAGEMENT OF THE INTERNAL CAROTID ARTERY ANEURYSM. THE REPORTED CASE IS A 53-YEAR-OLD MAN, WHO PRESENTED WITH A SYMPTOMATIC LEFT ICA ANEURYSM WITH A MAXIMUM DIAMETER OF 3.8 CM AND SIGNIFICANT DEVIATION OF THE ARTERY PRIOR TO THE ANEURYSM. IT WAS DECIDED TO PERFORM A HYBRID INTERVENTION. THE EXISTING ACUTE ANGLES OF THE ICA COULD CAUSE COMPLICATIONS DURING THE DELIVERY OF THE 7-FRENCH SYSTEM. THEREFORE, RESECTION OF THE ICA FOLLOWED BY REIMPLANTATION AND THEN COVERED STENTING OF THE ICA ANEURYSM WAS PERFORMED. THE ARTERY WAS SHORTENED BY 1.5 CM AND REIMPLANTED INTO THE BIFURCATION OF THE CCA BY PROLENE 6¿0 SUTURES UNDER 2.5 MAGNIFICATION (FIG. 3). THE REPORTED COMPLICATIONS INCLUDED THROMBOSIS AT THE RECONSTRUCTION SITE WHICH LEAD TO STROKE (N=1). IN CONCLUSION, EXTRACRANIAL ANEURYSMS OF THE ICA ARE VERY RARE PATHOLOGIES, SO AN INDIVIDUAL APPROACH IS REQUIRED FOR EVERY PATIENT. ENDOVASCULAR TECHNIQUES MAY BE USED IN SELECTED PATIENTS AS AN ALTERNATIVE TO OPEN SURGERY; HOWEVER, MORE STUDIES ARE REQUIRED TO DETERMINE LONG-TERM VASCULAR PATENCY AFTER THE PROCEDURE. THE HYBRID APPROACH CAN BE USED IN CASES WHEN IT IS CHALLENGING TO PERFORM PURELY ENDOVASCULAR INTERVENTION OR OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224633 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other