BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18816546 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02186
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    August 29, 2022
    Report Date
    March 1, 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
    UK
    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: CUREUS 14(8): E28529. HTTPS://DOI.ORG/10.7759/CUREUS.28529.

    Description of Event or Problem · 0

    TITLE: SUCCESSFUL CLOSURE OF POST-PNEUMONECTOMY BRONCHOPLEURAL FISTULA WITH SUTURE REPAIR REINFORCED WITH PORCINE ACELLULAR DERMAL MATRIX (PERMACOL) AND HYDROGEL SEALANT (PROGEL): A CASE REPORT. THIS STUDY REPORTS A CASE OF A 62-YEAR-OLD MALE WHO DEVELOPED A BRONCHOPLEURAL FISTULA (BPF) AFTER THE PATIENT UNDERWENT A LEFT PNEUMONECTOMY AND LYMPH DISSECTION THROUGH AN OPEN THORACOTOMY. A DECISION WAS MADE TO PROCEED WITH A REDO LEFT THORACOTOMY AND CLOSURE OF THE BPF SIX DAYS AFTER HIS BRONCHOSCOPY, ALLOWING TIME FOR THE PATIENT TO BE OPTIMISED WITH ANTIBIOTIC TREATMENT, A HIGH PROTEIN DIET, AND INTENSIVE CHEST PHYSIOTHERAPY. THE LEFT MAIN BRONCHIAL STUMP WAS DEBRIDED AND DIRECTLY REPAIRED WITH 3/0 AND 4/0 INTERRUPTED POLYPROPYLENE SUTURES (PROLENE, ETHICON, BRIDGEWATER, NJ). THE BRONCHIAL REPAIR WAS THEN REINFORCED WITH PERMACOL, WHICH WAS FIXED WITH INTERRUPTED 4/0 PROLENE SUTURES AND POLYTETRAFLUOROETHYLENE PLEDGETS (FIGURE 3). PROGEL WAS SUBSEQUENTLY APPLIED ON TOP OF THE REPAIR. THE REPAIRED STUMP WAS CHECKED UNDERWATER WITH AIRWAY PRESSURES UP TO 35 CMH2O, WITHOUT EVIDENCE OF AN AIR LEAK. THE THORACIC CAVITY WAS WASHED WITH POVIDONE-IODINE AND GENTAMICIN. TWO CHEST DRAINS WERE INSERTED AT THE BASE AND APEX OF THE THORACIC CAVITY, RESPECTIVELY, AND THE THORACOTOMY WAS CLOSED IN A STANDARD FASHION. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE WOUND SEROMA. IN CONCLUSION, THE USE OF PORCINE DERMAL COLLAGEN MATRIX COVERED WITH HYDROGEL SEALANT IS A VIABLE ALTERNATIVE TO TRADITIONAL BPF CLOSURE STRATEGIES AND CAN ACHIEVE GOOD PATIENT OUTCOMES. THIS TECHNIQUE HAS SEVERAL BENEFITS INCLUDING COST-EFFECTIVENESS AND SPARING OF NATIVE TISSUES, AND IT IS TECHNICALLY STRAIGHTFORWARD. FURTHER STUDIES ARE REQUIRED TO COMPARE THE CLINICAL OUTCOMES OF THIS AND OTHER NOVEL TECHNIQUES WITH TRADITIONAL BPF CLOSURE APPROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298162 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention