BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 9567055 · Received January 8, 2020

    Report

    Report Number
    2210968-2020-00215
    Event Type
    Injury
    Date Received
    January 8, 2020
    Report Date
    December 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: CASE REPORTS IN MEDICINE (2010) 1-3; DOI:10.1155/2010/213818. (B)(4).

    Description of Event or Problem · 1

    TITLE : ACUTE TENSION PNEUMOTHORAX FOLLOWING CARDIAC HERNIATION AFTER PNEUMONECTOMY THIS CASE REPORT PRESENTED A (B)(6)-YEAR-OLD WOMAN (HEIGHT 156 CM, WEIGHT (B)(6) KG), SHOWED SYMPTOMS OF CHRONIC COUGH, RECURRENT PULMONARY INFECTIONS, AND PRONOUNCED STRESS DYSPNEA. FURTHER EVALUATIONS REVEALED TUBERCULOSIS, TREATED SEVERAL YEARS WITH AN UNKNOWN MONOTHERAPY. THE RESPIRATORY FUNCTION TEST INDICATED MARKED RESTRICTED LUNG FUNCTION. A CHEST CT SCAN REVEALED RIGHT ACCENTUATED SEVERE BRONCHIECTASIS ACCOMPANIED BY PULMONARY EMPHYSEMA. DURING A RIGID BRONCHOSCOPY, A DAMAGE OF THE RIGHT MAIN STEM BRONCHUS AND MASSIVE PURULENT SECRETIONS OF THE RIGHT CAUDAL LUNG SECTIONS (AFFECTED BY ESCHERICHIA COLI) WERE FOUND. LUNG VENTILATION-PERFUSION SCINTIGRAPHY SHOWED A DISTRIBUTION OF VENTILATION OF 90% ON THE LEFT AND 10% ON THE RIGHT SIDE. THUS, DECISION FOR RIGHT PNEUMONECTOMY WAS MADE. PNEUMONECTOMY WAS PERFORMED THROUGH A LATERAL THORACOTOMY. TO REDUCE THE RISK OF POSTOPERATIVE BRONCHIAL STUMP DEHISCENCE, THE BRONCHIAL STUMP WAS COVERED WITH A PEDICLED PERICARDIAL FLAP, AND THE PERICARDIAL DEFECT WAS IMMEDIATELY REPAIRED WITH A VICRYL MESH (ETHICON). A CHEST TUBE WAS PLACED IN THE RIGHT CAVITY. AT THE END OF SURGERY, THE PATIENT WAS SUCCESSFULLY EXTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. A FEW HOURS LATER, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND SHOWED AN ANEMIA (HB: 6.7 G/DL). BECAUSE OF AN ASSUMED INTRATHORACIC HEMORRHAGE AND POSSIBLE CARDIAC HERNIATION, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. ON REOPENING OF THE THORACOTOMY, CARDIAC HERNIATION INTO THE RIGHT THORACIC CAVITY BECAUSE OF A RUPTURE OF THE VICRYL MESH WAS SEEN. SURGICAL TREATMENT INCLUDED SUTURE OF THE PULMONARY VEIN AND LEFT ATRIUM AS WELL AS REPAIR OF THE PERICARDIUM WITH A GORE-TEX PATCH WITH AN EXCELLENT POSTOPERATIVE RESULT. IN SUMMARY, THIS STUDY PRESENTED THE SUCCESSFUL TREATMENT OF A PATIENT WITH AN ACUTE TENSION PNEUMOTHORAX FOLLOWING CARDIAC HERNIATION AND INTRATHORACIC BLEEDING AFTER PNEUMONECTOMY. IMMEDIATE RE-THORACOTOMY AND NEEDLE THORACOCENTESIS ARE ESSENTIAL PROCEDURES IN SUCH CIRCUMSTANCES AND SHOULD BE CONDUCTED WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29511 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention