BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18787258 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-01894
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    June 1, 2023
    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: THORAC CARDIOVASC SURG 2023;165(6):2193-201. HTTPS://DOI.ORG/10.1016/J.JTCVS.2022.07.031. RELATED EVENTS CAPTURED VIA 2210968-2024-01891, 2210968-2024-01892, 2210968-2024-01893.

    Description of Event or Problem · 0

    TITLE: LIVING-DONOR SEGMENTAL LUNG TRANSPLANTATION FOR PEDIATRIC PATIENTS. THE AIM OF THIS STUDY IS TO EVALUATE THE OUTCOME OF LIVING-DONOR SEGMENTAL LUNG TRANSPLANTATION FOR PEDIATRIC PATIENTS. BETWEEN AUGUST 2009 AND MAY 2021, A TOTAL OF 6 CRITICALLY ILL PEDIATRIC PATIENTS [4 MALE AND 2 FEMALE; MEDIAN AGE OF 7 YEARS (RANGE, 4-15 YEARS); MEDIAN HEIGHT OF 112.7 CM (RANGE, 95-125.2 CM)] UNDERWENT A LIVING-DONOR SEGMENTAL LUNG TRANSPLANTATION, INCLUDING 1 PATIENT ON A VENTILATOR ALONE AND ANOTHER PATIENT ON A VENTILATOR AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE DIAGNOSES INCLUDED COMPLICATIONS OF ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (N=4) AND PULMONARY FIBROSIS (N=2). A BASAL SEGMENT AND A LOWER LOBE WERE IMPLANTED IN 3 PATIENTS, AND A BASAL SEGMENT AND AN S6 SEGMENT WERE IMPLANTED IN THE OTHER 3 PATIENTS. IN 2 PATIENTS, THE RIGHT S6 SEGMENTAL GRAFT WAS HORIZONTALLY ROTATED 180° AND IMPLANTED AS THE LEFT LUNG. THE BRONCHUS WAS ANASTOMOSED TO THE RECIPIENT¿S LEFT UPPER BRONCHUS WITH RUNNING 5-0 POLYDIOXANONE (PDS) SUTURES FOR THE MEMBRANOUS PORTION AND INTERRUPTED 5-0 PDS SUTURES FOR THE CARTILAGINOUS PORTION. THE PULMONARY VEIN OF THE GRAFT WAS ANASTOMOSED TO THE INFERIOR PULMONARY VEIN OF THE RECIPIENT WITH RUNNING 6-0 PROLENE SUTURES. THE PULMONARY ARTERY WAS RECONSTRUCTED BY DIRECT END-TO-END ANASTOMOSIS WITH RUNNING 7-0 PROLENE SUTURES. TEMPORARY CHEST CLOSURE WITHOUT RIB APPROXIMATION WAS PERFORMED USING EXPANDED POLYTETRAFLUOROETHYLENE SHEETS. REPORTED COMPLICATIONS AND OUTCOME INCLUDES THE FOLLOWING: CASE 4: 4-YEAR-OLD MALE PATIENT (N=1). PULMONARY GRAFT CONGESTION. TREATMENT: THE SUPERIOR SEGMENTAL VEIN WAS RE-ANASTOMOSED AFTER WIDENING THE RECIPIENT¿S VENOUS STUMP TO IMPROVE THE VENOUS DRAINAGE ON POD 2, WHICH GRADUALLY AMELIORATED PULMONARY EDEMA IN THE S6 SEGMENTAL GRAFT BILATERAL LONG-TERM PERSISTENT AIR LEAKAGE. TREATMENT: REPEATEDLY REQUIRED PLEURODESIS BY MINOCYCLINE AND AN AUTOLOGOUS BLOOD PATCH. IN CONCLUSION, LIVING-DONOR SEGMENTAL LUNG TRANSPLANTATION WAS A TECHNICALLY DIFFICULT BUT FEASIBLE PROCEDURE WITH ACCEPTABLE OUTCOMES FOR SMALL PEDIATRIC PATIENTS WITH CHEST CAVITIES THAT WERE TOO SMALL FOR ADULT LOWER LOBE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118046 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention