BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18836729 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02371
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    September 11, 2023
    Report Date
    March 5, 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
    CH
    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. CITATION: JOURNAL OF THORACIC DISEASE, (2023); 15 (9): 5122-5133. HTTPS://DX.DOI.ORG/10.21037/JTD-23-1128. RELATED EVENTS CAPTURED VIA 2210968-2024-02368, 2210968-2024-02369, 2210968-2024-02370, 2210968-2024-02371.

    Description of Event or Problem · 0

    TITLE: SUCCESSFUL REPAIR OF ACQUIRED INTRATHORACIC NONMALIGNANT TRACHEOESOPHAGEAL FISTULAS USING THORACOACROMIAL ARTERY PERFORATOR FLAP THROUGH A MIDSTERNAL INCISION APPROACH: A REPORT OF THREE CASES. THREE CONSECUTIVE SURGICAL REPAIRS WITH TAPFS WAS PERFORMED IN 3 PATIENTS BETWEEN (B)(6) 2021 AND (B)(6) 2022. DURING THE PROCEDURE, A MIDSTERNAL INCISION WAS MADE. AFTER THE THYMUS AND ANTERIOR MEDIASTINAL FAT WERE RESECTED, AND THE LEFT INNOMINATE VEIN WAS TRANSECTED, THE TRACHEA AND ESOPHAGUS WERE MOBILIZED. THE TRACHEA WAS INCISED AND PULLED TO THE CRANIAL AND CAUDAL SIDES. THEN, THE THORACOACROMIAL ARTERY PERFORATOR FLAP WAS HARVESTED AND TRANSFERRED INTO THE SUPERIOR MEDIASTINUM FOR ESOPHAGEAL RECONSTRUCTION USING INTERRUPTED 2-0 ETHIBOND SUTURES. SUBSEQUENTLY, THE TRACHEA WAS ANASTOMOSED END TO END AFTER DEBRIDEMENT USING 3-0 PROLENE SUTURES, AND THE LEFT INNOMINATE VEIN WAS EITHER ANASTOMOSED OR NOT. AFTER 6 MONTHS OF FOLLOW-UP, NO RECURRENCE HAS BEEN OBSERVED. AT THE SAME TIME, THE PROBLEM OF POSTOPERATIVE ESOPHAGEAL STRICTURE HAS BEEN SOLVED BY ENLARGING THE ESOPHAGEAL LUMEN THROUGH SKIN FLAPS, IMPROVING THE QUALITY OF POSTOPERATIVE LIFE. THE MEAN FOLLOW-UP PEIOD WAS UNKNOWN. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION (2-0 ETHIBOND, 3-0 PROLENE SUTURES): > PATIENT 2 (58 YEARS OLD, FEMALE) -ESOPHAGEAL ANASTOMOTIC LEAKAGE, MANIFESTING AS TRANSITORY FEVER AND MURKY DRAINAGE. TREATMENT: DRAINAGE AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584322 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention