BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19031324 · Received April 3, 2024

    Report

    Report Number
    2210968-2024-03786
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    October 9, 2023
    Report Date
    April 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CITATIONS : JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS &TECHNIQUES . VOL.9 ( 4) 1-4. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2023.101356.

    Description of Event or Problem · 0

    TITLE : A NOVEL RADIAL ARTERY TO RADIAL VEIN ARTERIOVENOUS FISTULA CREATION TECHNIQUE FOR LONG-TERM DIALYSIS ACCESS. THE REPORTED CASE WAS A 69-YEAR-OLD MAN WHO PRESENTED WITH A RELEVANT MEDICAL HISTORY OF HYPERTENSION, CONGESTIVE HEART FAILURE, HYPERLIPIDEMIA, AND A 30-PACK-YEAR SMOKING HISTORY WITH CKD STAGE 5, BEFORE DIALYSIS. THE PATIENT HAD NO ADEQUATE SUPERFICIAL VENOUS OUTFLOW IN EITHER UPPER EXTREMITY, WITH ULTRASOUND DEMONSTRATING INADEQUATE CEPHALIC AND BASILIC VEINS WITH A MAXIMUM DIAMETER OF 1.5 MM AND NON SCLEROTIC, NON STENOTIC PAIRED BRACHIAL VEINS WITH A MINIMUM DIAMETER 3.0 MM IN EACH BRACHIAL VEIN. THE DECISION WAS MADE TO PROCEED WITH AVG PLACEMENT. THE PATIENT¿S NONDOMINANT ARM WAS PREPARED AND DRAPED FOR FOREARM BRACHIAL ARTERY TO BRACHIAL VEIN LOOP AVG CREATION. AN INCISION WAS MADE DIRECTLY OVER THE RADIAL VASCULAR BUNDLE FROM THE PROXIMAL RADIAL BUNDLE TO THE WRIST, STOPPING JUST SHORT OF THE ANASTOMOSIS. THE FASCIA WAS THEN CLOSED UNDER THE VEIN WITH VICRYL SUTURE (ETHICON), AND THE VEIN WAS GENTLY SECURED IN PLACE WITH VICRYL SUTURE UNDER THE LATERAL SKIN FLAP AND, THUS, LATERAL TO THE INCISION. THE REPORTED COMPLICATIONS INCLUDED FAILURE OF THE VEIN TO MATURE AND AN INCREASED BLEEDING TIME AND VENOUS PRESSURE. IN CONCLUSION, WE BELIEVE THAT FOR SELECT PATIENTS WITH THE APPROPRIATE ANATOMY, RADIAL ARTERY TO RADIAL VEIN FISTULA CREATION IS A VIABLE OPTION FOR AUTOLOGOUS DIALYSIS ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607602 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention