BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18784707 · Received February 26, 2024

    Report

    Report Number
    2210968-2024-01929
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    April 1, 2022
    Report Date
    February 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CITATION: NEUROL MED CHIR (TOKYO) APRIL, 2022; 62:203-208. HTTPS://DOI.ORG/10.2176/JNS-NMC.2021-0355.

    Description of Event or Problem · 0

    TITLE: MODIFIED SHOELACE DURAL CLOSURE WITH COLLAGEN MATRIX IN EXTENDED TRANSSPHENOIDAL SURGERY. THE AIM OF THIS STUDY IS TO PRESENT A NOVEL SELLAR RECONSTRUCTION METHOD USING COLLAGEN MATRIX (MODIFIED SHOELACE DURAL CLOSURE) IN EXTENDED ETSS, WHICH CAN ELIMINATE THE ADDITIONAL HARVEST OF AUTOLOGOUS TISSUE GRAFTS. BETWEEN AUGUST 2019 AND OCTOBER 2021, A TOTAL OF 18 PATIENTS (9 MALE AND 9 FEMALE; MEAN AGE OF 50.6 (RANGE, 9-74 YEARS) YEARS) UNDERWENT MODIFIED SHOELACE DURAL CLOSURE AFTER LESIONECTOMY VIA EXTENDED ETSS. THE CLINICAL DIAGNOSIS WAS CRANIOPHARYNGIOMA IN 10 PATIENTS; PITUITARY ADENOMA, MENINGIOMA, AND RATHKE¿S CLEFT CYST IN 2 PATIENTS; AND SELLAR ARACHNOID CYST AND XANTHOGRANULOMA IN 1 PATIENT. THREE CASES OF CRANIOPHARYNGIOMA AND ONE CASE OF PITUITARY ADENOMA WERE RECURRENT CASES. INTRAOPERATIVE CSF LEAKAGE WAS CLASSIFIED AS GRADE 3 BASED ON ESPOSITO¿S CSF LEAK GRADING SYSTEM19) IN ALL PATIENTS. IN THIS TECHNIQUE, A COLLAGEN MATRIX, WHICH WAS PLACED SUBDURALLY (INLAY GRAFT), WAS CONTINUOUSLY SUTURED BY A 6-0 PROLENE DOUBLE-ARMED SUTURES WITH BOTH OPEN DURAL EDGES LIKE A SHOELACE. THEN, ANOTHER COLLAGEN MATRIX WAS PLACED EPIDURALLY (ONLAY GRAFT), AND RIGID RECONSTRUCTION WAS PERFORMED USING THE SEPTAL BONE AND A RESORBABLE FIXATION MESH (COMPETITOR). REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE CSF LEAKAGE (N=1). IN CONCLUSION, THIS TECHNIQUE COULD SERVE AS AN EXCELLENT OPTION FOR SELLAR RECONSTRUCTION IN SELECTED PATIENTS WITH A MINIMAL RATE OF POSTOPERATIVE CSF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669358 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention