BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23287241 · Received October 15, 2025

    Report

    Report Number
    2210968-2025-11742
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. CITATION: THORACIC SURGERY, VOL. 78, NO. 3: 176-179, 2025.

    Description of Event or Problem · 0

    TITLE: INTERCOSTAL PULMONARY HERNIATION FOLLOWING MINIMALLY INVASIVE MITRAL VALVULOPLASTY. THE AIM OF THIS STUDY IS TO REPORT ON THE USE OF A MESH PLATE IN HERNIA REPAIR, WITH FAVORABLE RESULTS. A 67 AGE, MALE WITH MAIN COMPLAINT OF SUBCUTANEOUS EMPHYSEMA. FIVE YEARS AGO, THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT BY MEDIAN STERNOTOMY IN OUR HOSPITAL. SHE HAD BREATHING DIFFICULTY 3 MONTHS AGO AND VISITED OUR HOSPITAL. DETAILED EXAMINATION REVEALED SEVERE MITRAL VALVE INCOMPETENCE DUE TO NEW MITRAL VALVE PROLAPSE. SURGERY WAS CONSIDERED INDICATED, AND MITRAL VALVULOPLASTY BY FOURTH INTERCOSTAL THORACOTOMY [P2 EXCISION, 1 ARTIFICIAL TENDON, CG FUTURE 30 MM (MEDTRONIC)] WAS PERFORMED. HOWEVER, SUBCUTANEOUS EMPHYSEMA WORSENED ON POSTOPERATIVE DAY 4, AND CT SHOWED PULMONARY HERNIA. THEREFORE, PULMONARY HERNIA REPAIR WAS URGENTLY PERFORMED. WHEN THE WOUND AT THE PREVIOUS SURGERY WAS INCISED, THE INTERCOSTAL SPACE WAS OPEN, AND THE PDS1MM (ETHICON CO., LTD.) USED FOR CLOSURE OF THE INTERCOSTAL SPACE WAS CUT OFF. A WATER TEST SHOWED NO OBVIOUS DAMAGE SITE, AND A GRANDFIX FLEXI-MESH PLATE (GUNZE MEDICAL CO., LTD.) WAS PLACED BETWEEN THE UPPER AND LOWER RIBS, AND THE INTERCOSTAL SPACE WAS CLOSED WITH TWO PDS1MM. REPORTED COMPLICATION IS: PDS SUTURE (1MM; ETHICON) (N=1; 67 AGE, MALE) SUBCUTANEOUS EMPHYSEMA WORSENED ON THE DAY AFTER SURGERY TREATMENT: THE DRAIN WAS REPLACED AND THE INSERTION SITE WAS COMPRESSED. IN CONCLUSION, IN THIS CASE, IT WAS AFTER MEDIAN STERNOTOMY, AND THE SKIN INCISION WAS ABOUT 6 CM, BUT IT WAS HIGHLY LIKELY THAT 9 CM OR MORE OF INTERCOSTAL SPACE WAS INCISED TO SECURE VISUAL FIELD. TAKING THIS INTO CONSIDERATION, THE INTERCOSTAL SPACE WAS CLOSED WITH PDS. IT WAS FOUND THAT THE PDS WAS CUT OFF WHEN THE INTERCOSTAL PULMONARY HERNIA WAS REPAIRED. IT WAS CONSIDERED THAT THE RISK OF RECURRENCE IS HIGH EVEN IF THE CHEST IS CLOSED IN THE SAME MANNER. SINCE CLOSURE OF PULMONARY HERNIA WITH A MESH PLATE HAS BEEN REPORTED, THE CHEST WAS CLOSED WITH A MESH PLATE IN THIS CASE AS WELL. AFTER THE REPAIR, THERE WAS NO RECURRENCE OF PULMONARY HERNIA, AND GOOD RESULTS WERE OBTAINED. IN THIS CASE, THERE WAS NO RISK EXCEPT THAT THE DEGREE OF INTERCOSTAL THORACOTOMY WAS 9 CM AND 9 CM. IN ADDITION, PULMONARY HERNIATION OCCURRED DESPITE CHEST CLOSURE THREADS WERE ATTACHED AT THE TIME OF CHEST CLOSURE. IF EITHER OF THE RISKS IS APPLICABLE, IT WAS CONSIDERED NECESSARY TO CONSIDER CHEST CLOSURE USING MESH PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791186 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention