BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22172330 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06546
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 26, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J VASC SURG CASES INNOV TECH. 2024 JUN 5;10(5):101552. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2024.101552. PMID: 39281287; PMCID: PMC11400978.

    Description of Event or Problem · 0

    DELAYED ABDOMINAL AORTIC ANEURYSM SAC RUPTURE AFTER OPEN REPAIR. THE AIM OF THE STUDY WAS TO REPORT A CASE OF A 74-YEAR-OLD ASIAN MALE WITH DELAYED RUPTURE OF AN ENLARGING AAA SAC AFTER OPEN REPAIR REQUIRING RE-EXPLORATION IN A PATIENT PRESENTING WITH FLANK PAIN AND IPSILATERAL HYDRONEPHROSIS. THE NATURAL HISTORY OF A LARGE, EXCLUDED ANEURYSM SAC AFTER OPEN AAA REPAIR, HYPOTHESIZED ETIOLOGY FOR THIS RARE OCCURRENCE, AND PROPOSED DIAGNOSTIC AND THERAPEUTIC ALGORITHM ARE DESCRIBED. VICRYL (ETH) SUTURE WAS USED TO CLOSED THE RETROPERITONEUM. REPORTED COMPLICATIONS: VICRYL (ETH). 74-YEAR-OLD ASIAN MALE (N=1). FLANK PAIN. TREATMENT: REOPENED SURGERY. ENLARGING ABDOMEN. TREATMENT: REOPENED SURGERY. PERSISTENT ILEUS. TREATMENT: NOT REPORTED. IN CONCLUSION, ANEURYSM SAC ENLARGEMENT CAN RARELY OCCUR AFTER OPEN (AND DEFINITIVE) AAA REPAIR. IN INSTANCES WHERE A LARGE PERIGRAFT FLUID COLLECTION IS ENCOUNTERED, CROSS-SECTIONAL OR DIGITAL SUBTRACTION CONTRAST IMAGING MAY HELP DETERMINE WHETHER A LEAK IS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318741 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention