BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP*ENDO

    MDR report key: 7880832 · Received September 17, 2018

    Report

    Report Number
    3005075853-2018-12784
    Event Type
    Injury
    Date Received
    September 17, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/17/2018. BATCH # UNKNOWN. BATCH #UNK. AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: INCLUSION OF THE LEFT MAIN BRONCHUS IN THE CLIP USED TO OCCLUDE THE DUCTUS ARTERIOSUS IN A PREMATURE BABY: AN UNEXPECTED COMPLICATION. AUTHORS: AKHLAQUE N BHAT, JIJU JOHN, MOHAMMED KR RIYAS, BADER ALKURDI , HUSAM SALAMA. CITATION: INDIAN JOURNAL OF ANAESTHESIA. 2014; 58 (2). DOI: 10.4103/0019-5049.130838. THE AUTHORS PRESENTED AN UNUSUAL CASE WHERE THE LEFT MAIN BRONCHUS WAS OCCLUDED ALONG WITH THE PDA WITHIN THE SAME LIGACLIP. A BABY GIRL WEIGHING 780 G WAS BORN AT (B)(6) WEEKS OF GESTATION. AT (B)(6) DAYS OF AGE, HER PATENT DUCTUS ARTERIOSUS (PDA) MEASURING 5-6 MILLIMETERS REMAINED PATENT DESPITE A COURSE OF ORAL IBUPROFEN AND INTRAVENOUS INDOMETHACIN. AS IT WAS DIFFICULT TO WEAN HER FROM CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) VENTILATION, A DECISION TO LIGATE THE PDA WAS MADE. DURING THE SURGICAL PROCEDURE, THE LEFT HEMITHORAX WAS ACCESSED THROUGH A THIRD SPACE POSTEROLATERAL THORACOTOMY AND THE PDA WAS CAREFULLY DISSECTED. A MEDIUM-LARGE LIGACLIP (ETHICON) WAS USED TO OCCLUDE THE PDA. SOON AFTER PDA CLOSURE, THE OXYGEN SATURATIONS DROPPED TO THE MID-80S AND LEFT LUNG WAS FOUND TO BE PARTIALLY COLLAPSED. POSTOPERATIVE CHEST RADIOGRAPH REVEALED COMPLETE COLLAPSE OF THE LEFT LUNG. FURTHER EXAMINATION AND RE-EXPLORATION REVEALED THE APPLICATION OF THE LIGACLIP ACROSS THE DUCTUS ARTERIOSUS WITH INCLUSION OF THE LEFT MAIN BRONCHUS IN THE CLIP. CAREFUL DISSECTION WAS DONE AND THE CLIP WAS REMOVED. THE LEFT MAIN BRONCHUS WAS THEN REPAIRED. LIGATION OF A LARGE PDA IN PREMATURE BABIES CARRIES A RISK OF LEFT MAIN BRONCHUS INJURY. AT THE END OF THE PROCEDURE THE PRESENCE OF A COLLAPSED LEFT LUNG SHOULD RAISE THE SUSPICION OF BRONCHIAL OCCLUSION. IF IN DOUBT ABOUT THE EXACT NATURE OF THE INJURY, A BRONCHOSCOPY AND/OR A CT SCAN SHOULD BE PERFORMED PRIOR TO UNDERTAKING SURGICAL RE-EXPLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721206 LIGACLIP*ENDO CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1