BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22203008 · Received June 13, 2025

    Report

    Report Number
    2210968-2025-06843
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    March 18, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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. 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: FRONT CARDIOVASC MED. 2024 MAR 18;11:1345726. HTTPS://DOI.ORG/10.3389/FCVM.2024.1345726. PMID: 38562186; PMCID: PMC10982407.

    Description of Event or Problem · 0

    TITLE: ASSOCIATION OF HBA1C AND UTILIZATION OF INTERNAL MAMMARY ARTERIES WITH WOUND INFECTIONS IN CABG. THE AIM OF THIS STUDY IS TO PERFORM THIS STRATIFICATION AT A HIGH-VOLUME TERTIARY HEART CENTER AND CORRELATE THESE SUBSETS OF DIABETIC PATIENTS WITH POSTOPERATIVE OUTCOMES WITH A SPECIAL EMPHASIS ON WHD (WOUND HEALING DISORDER) AND DSWI (DEEP STERNAL WOUND INFECTION). BETWEEN JANUARY 2010 AND AUGUST 2020, A TOTAL OF 229 PATIENTS UNDERWENT ISOLATED CABG WHILE USING VICRYL SUTURES. REPORTED COMPLICATIONS ARE: N=114; WOUND HEALING DISORDER. TREATMENT: NOT MENTIONED. N=37; DEEP STERNAL WOUND INFECTION. TREATMENT: NOT MENTIONED. N=63; MYOCARDIAL INFARCTION. TREATMENT: NOT MENTIONED. N=58; STROKE. TREATMENT: NOT MENTIONED. N=204; RENAL FAILURE. TREATMENT: NOT MENTIONED. N=25; SEPSIS. TREATMENT: NOT MENTIONED. IN CONCLUSION, CABG PRESENTS EXCELLENT SHORT-TERM OUTCOMES IN TERMS OF MORTALITY, STROKE, AND MYOCARDIAL INFARCTION INDEPENDENT FROM PREOPERATIVE HBA1C LEVELS WITH NO INCREASE OF DSWI, BUT HIGHER RATES OF WHD AND RENAL FAILURE IN PATIENTS WITH POOR DIABETIC STATUS AND HBA1C GREATER THAN OR EQUAL TO 6.5%. INTRAOPERATIVE UTILIZATION OF BIMA IS NOT CONNECTED WITH AN INCREASE OF DSWI BUT HIGHER RATES OF WHD IN PATIENTS WITH POOR DIABETIC STATUS AND HBA1C GREATER THAN OR EQUAL TO 6.5%. THEREFORE, THE APPLICATION OF BIMA SHOULD BE TAKEN INTO CONSIDERATION IN CABG EVEN IN PATIENTS WITH POOR DIABETIC STATUS, WHILE THE IDENTIFICATION OF SPECIAL SUBSETS OF PATIENTS WHO ARE AT PARTICULAR HIGH RISK FOR DSWI IS OF PARAMOUNT IMPORTANCE TO PREVENT THIS SERIOUS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376988 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other