BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23006342 · Received September 9, 2025

    Report

    Report Number
    2210968-2025-10252
    Event Type
    Injury
    Date Received
    September 9, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. CITATION: ANN VASC SURG. 2025 JUN; 115:83-92. HTTPS://DOI.ORG/10.1016/J.AVSG.2025.02.013 EPUB 2025 MAR 11. PMID: 40081528.

    Description of Event or Problem · 0

    TITLE: BEYOND ENDOVASCULAR SOLUTIONS: OPEN SAC REVISION WITH GRAFT PRESERVATION FOR PERSISTENT AORTIC SAC EXPANSION POST-EVAR. THE AIM OF THIS RETROSPECTIVE STUDY IS TO PRESENT A CASE OF SEVENTEEN PATIENTS (MEDIAN AGE: 82 YEARS, PREDOMINANTLY MALE) UNDERWENT OPEN SAC REVISION (OSR) WITH GRAFT PRESERVATION FOLLOWING EVAR FOR INFRARENAL AAA BETWEEN JANUARY 2010 AND OCTOBER 2023 AT A TERTIARY CARE FACILITY SERVING AS A REGIONAL VASCULAR SURGERY CENTER. PROLENE SUTURE (ETH) WAS USED TO PLACE TO SECURE THE SEALING AND JUNCTIONAL ZONES OF THE ENDOGRAFT TO ALLOW SAFER MANIPULATION OF THE ENDOGRAFT AND REDUCE THE RISK OF FUTURE ENDOLEAK. REPORTED COMPLICATIONS: PROLENE SUTURE (ETH) TYPE 2 ENDOLEAK (N=9) TREATMENT: ENDOVASCULAR REINTERVENTION ADDITIONAL TYPE 1 ENDOLEAK (N=1) TREATMENT: ENDOVASCULAR REINTERVENTION AORTIC SAC EXPANSION (N=5) TREATMENT: ENDOVASCULAR REINTERVENTION ONGOING SAC EXPANSION WITH RECURRENT ENDOLEAK (N=2) TREATMENT: SECONDARY ENDOVASCULAR REINTERVENTION. IN CONCLUSION, OSR WITH GRAFT PRESERVATION IS EFFECTIVE FOR SAC EXPANSION POST-EVAR, FACILITATING ENDOLEAK IDENTIFICATION AND REPAIR WHILE AVOIDING AORTIC CLAMPING. ONGOING SURVEILLANCE IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824458 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention