BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18857228 · Received March 7, 2024

    Report

    Report Number
    2210968-2024-02613
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    March 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. 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 RELATED EVENTS CAPTURED VIA 2210968-2024-02613 AND 2210968-2024-02614 CITATION: HTTPS://DOI.ORG/10.1016/J.JVSCIT.2023.101178.

    Description of Event or Problem · 0

    TITLE: ABDOMINAL AORTIC ANEURYSM AND BILATERAL PELVIC KIDNEYS THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE A RARE CASE OF BILATERAL ECTOPIC KIDNEYS IN THE SETTING OF OPEN ABDOMINAL AORTIC ANEURYSM REPAIR USING THE DESCRIBED TECHNIQUE. A 61-YEAR-OLD MAN PRESENTED WITH A CENTERLINE DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) OF 5.8 CM, WITH AN INCIDENTAL FINDING OF BILATERAL ECTOPIC KIDNEYS. A 61-YEAR-OLD MAN PRESENTED WITH A CENTERLINE DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) OF 5.8 CM, WITH AN INCIDENTAL FINDING OF BILATERAL ECTOPIC KIDNEYS. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY ILEUS, WHICH RESOLVED WITH CONSERVATIVE MANAGEMENT. HIS POSTOPERATIVE CREATININE LEVELS AND URINE OUTPUT REMAINED NORMAL. THE AAA WAS REPAIRED USING AN 18-MM STRAIGHT DACRON TUBE GRAFT IN STANDARD FASHION WITH 3-0 PROLENE SUTURE. THE FOGARTY OCCLUSION CATHETERS WERE REMOVED BEFORE COMPLETION OF THE ANASTOMOSIS. THE AORTIC SAC WAS CLOSED OVER THE REPAIR USING 2-0 VICRYL SUTURE. REPORTED COMPLICATION INCLUDES POSTOPERATIVE ILEUS. IN CONCLUSION, ALTHOUGH MULTIPLE METHODS TO ENSURE ADEQUATE RP TO A SINGLE PELVIC KIDNEY ASSOCIATED WITH OPEN AAA REPAIR HAVE BEEN DESCRIBED, REPORTS OF BILATERAL PELVIC KIDNEYS REMAIN RARE. WE CONCLUDE THAT FASTIDIOUS BOLUS INFUSION OF COLD PRESERVATION SOLUTION AND A SHORT CLAMP TIME DURING OPEN AAA REPAIR IN THE SETTING OF BILATERAL PELVIC KIDNEYS IS A SAFE AND EFFICACIOUS METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976593 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other