BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22331650 · Received June 25, 2025

    Report

    Report Number
    2210968-2025-07449
    Event Type
    Death
    Date Received
    June 25, 2025
    Date of Event
    January 6, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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/DEATH 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? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INT J ACAD MED PHARM 2025; 7 (1); 6-10. DOI: 10.47009/JAMP.2025.7.1.2.

    Description of Event or Problem · 0

    TITLE: INSTITUTIONAL EXPERIENCE ON COMPARISON OF ALLOGRAFTS WITH MULTIPLE-RENAL ARTERY VS. SINGLE RENAL ARTERY IN LIVING AND DECEASED DONOR TRANSPLANTATION THE AIM OF THIS STUDY IS TO COMPARE UROLOGICAL (URINE LEAK AND STENOSIS) AND VASCULAR COMPLICATIONS (RENAL ARTERY AND VEIN THROMBOSIS) IN RENAL ALLOGRAFTS WITH A SINGLE ARTERY VS. MULTIPLE ARTERIES. ADDITIONALLY, THE SECONDARY OBJECTIVES INCLUDED ASSESSING DELAYED GRAFT FUNCTION AND GRAFT SURVIVAL AT 3- AND 6-MONTHS POST-TRANSPLANTATION. BETWEEN APRIL 2022 TO APRIL 2024, A TOTAL OF E 95 PATIENTS, 67.4% (64) WERE MALE, AND 32.6% (31) WERE FEMALE. THE MEAN AGE OF THE PARTICIPANTS WAS 34.65 ± 10.41 YEARS. FOR MRA GRAFTS A POLYPROPYLENE SUTURES (PROLENE 6-0; ETHICON) WAS USED FOR THE VASCULAR CONNECTIONS. AT THE SAME TIME IN ALL CASE, MODIFIED LICH-GREGOIR URETERONEOCYSTOSTOMY WAS PERFORMED USING 5-0 POLYGLACTIN SUTURES (VICRYL; ETHICON). REPORTED COMPLICATIONS ARE : POLYPROPYLENE SUTURES (PROLENE 6-0; ETHICON). -ACUTE TUBULAR NECROSIS (N=10). TREATMENT: NOT PROVIDED. -VASCULAR COMPLICATIONS (N=3). TREATMENT: NOT PROVIDED. -UROLOGICAL COMPLICATION (N=5). TREATMENT: NOT PROVIDED. 5-0 POLYGLACTIN SUTURES (VICRYL; ETHICON). -ACUTE TUBULAR NECROSIS (N=10). TREATMENT: NOT PROVIDED. -VASCULAR COMPLICATIONS (N=3). TREATMENT: NOT PROVIDED. -EXPERIENCING GRAFT FAILURE (N=1). TREATMENT: NOT PROVIDED. -UROLOGICAL COMPLICATION (N=5). TREATMENT: NOT PROVIDED. POLYPROPYLENE SUTURES (PROLENE 6-0; ETHICON) -MORTALITY WAS OBSERVED, ALL OF WHICH WERE ATTRIBUTED TO SEPSIS (N=3). TREATMENT: NOT PROVIDED. 5-0 POLYGLACTIN SUTURES (VICRYL; ETHICON). -MORTALITY WAS OBSERVED, ALL OF WHICH WERE ATTRIBUTED TO SEPSIS (N=3). TREATMENT: NOT PROVIDED. IN CONCLUSION, THIS STUDY DEMONSTRATES THAT RENAL TRANSPLANTATION OUTCOMES ARE SUPERIOR TO THOSE OF SINGLE RENAL ARTERY ALLOGRAFTS COMPARED TO THOSE OF MULTIPLE RENAL ARTERIES. IMMEDIATE GRAFT FUNCTION PLAYS A CRITICAL ROLE IN ENSURING GRAFT SURVIVAL AND MULTIPLE RENAL ARTERIES ARE ASSOCIATED WITH HIGHER VASCULAR COMPLICATIONS AND MORTALITY. THESE FINDINGS HIGHLIGHT THE IMPORTANCE OF SURGICAL EXPERTISE, METICULOUS PERIOPERATIVE CARE, AND TARGETED POSTOPERATIVE MANAGEMENT OF PATIENTS WITH ANATOMICALLY COMPLEX ALLOGRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129275 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R