BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 23612300 · Received November 20, 2025

    Report

    Report Number
    2210968-2025-13053
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    June 26, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. CITATION: JTCVS TECH. 2025 JUN 26;33:1-12. HTTPS://DOI.ORG/10.1016/J.XJTC.2025.06.018 PMID: 41112481; PMCID: PMC12529702.

    Description of Event or Problem · 0

    TITLE: SUTURELESS TOTAL ARCH REPLACEMENT IN PATIENTS WITH ACUTE TYPE A AORTIC DISSECTION. THE AIM OF THIS RETROSPECTIVE,SINGLE-CENTER COHORTSTUDY IS TO COMPARES THE SAFETY AND EFFICACY OF THE SUTURELESS TOTAL ARCH REPLACEMENT WITH CONVENTIONAL TOTAL ARCH REPLACEMENT. BETWEEN 2019 AND 2023, 382 PATIENTS WERE INCLUDED IN THIS STUDY WHO UNDERWENT ACUTE TYPE A AORTIC DISSECTION REPAIR INVOLVING ASCENDING AORTIC REPLACEMENT, TOTAL ARCH REPLACEMENT, AND THE FROZEN ELEPHANT TRUNK PROCEDURE. MERSILENE TAPE (ETH) WAS USED TO SECURED THE PROXIMAL ANASTOMOSIS AND THE GRAFT WITH TITANIUM LOOP THAT WAS INSERTED INTO THE PROXIMAL INCISION OF THE AORTA, AVOIDING THE CORONARY ARTERY OPENINGS. REPORTED COMPLICATIONS: MERSILENE TAPE (ETH) STAR GROUP (N=77) MESENTERIC ISCHEMIA (N=28, 7.3%) TREATMENT: NOT REPORTED DUE TO POSTOPERATIVE BLEEDING (N=12, 3.1%). TREATMENT: REOPERATION UNKNOWN EVENT (N=1.6%) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD THE NEED FOR MECHANICAL CIRCULATORY SUPPORT WAS (EXTRACORPOREAL MEMBRANE OXYGENATION 1.3% AND INTRA-AORTIC BALLOON PUMP 0.3%) WITH UNKNOWN CAUSE PNEUMONIA (N=16) TREATMENT: NOT REPORTED SEPSIS (N=9) TREATMENT: NOT REPORTED PNEUMONIA AND SEPSIS (N=1) TREATMENT: NOT REPORTED IN CONCLUSION, SUTURELESS TOTAL ARCH REPLACEMENT IMPROVES OPERATIVE EFFICIENCY AND BLEEDING CONTROL IN ACUTE TYPE A AORTIC DISSECTION REPAIRS AND IS ASSOCIATED WITH LOWER IN-HOSPITAL MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441619 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention