BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8001520 · Received October 24, 2018

    Report

    Report Number
    2210968-2018-76751
    Event Type
    Injury
    Date Received
    October 24, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (NUROLON SUTURE) CAUSED AND/OR CONTRIBUTED TO THE ARACHNOID EDGE BLEEDING DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: TURK NEUROSURG. 2015; 25 (5): 788-792 . DOI: 10.5137/1019-5149.JTN.10453-14.1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: HYDRANENCEPHALY: CONSIDERING PROLONGED SURVIVAL AND TREATMENT BY ENDOSCOPIC CHOROID PLEXUS COAGULATION" AUTHORS: COBY RAY, JAMES MOBLEY , MARK THOMPSON, LASZLO NAGY. CITATION: TURK NEUROSURG. 2015; 25 (5): 788-792. DOI: 10.5137/1019-5149.JTN.10453-14.1. ARACHNOID COLLAPSE IS A PREVIOUSLY UNREPORTED COMPLICATION OF ENDOSCOPIC CHOROID PLEXUS COAGULATION (ECPC) TREATMENT OF HYDRANENCEPHALY AND IS DEMONSTRATED IN THIS CASE REPORT. THE CASE PRESENTED DEMONSTRATES A PREVIOUSLY UNREPORTED COMPLICATION OF ECPC ¿ ARACHNOID COLLAPSE. THE ANATOMICAL ANOMALIES FOUND IN HYDRANENCEPHALY DO SUPPORT THE USE OF ECPC YET AT THE SAME TIME PREDISPOSE THE PROCEDURE TO THIS UNIQUE COMPLICATION. THIS PATIENT WAS BORN FULL-TERM BY CESAREAN SECTION. THE PREGNANCY OF THE MOTHER WAS COMPLICATED BY GESTATIONAL DIABETES AND OBESITY. A DIAGNOSIS OF HYDRANENCEPHALY WAS MADE ON A PRENATAL ULTRASOUND. OTHER COMPLICATIONS INCLUDED SEVERE MACROCEPHALY, DILATED VEINS, SUNSET SIGN, BULGING FONTANEL WITH SUTURAL DIASTASIS, PALPABLE SPINE DEFORMITY OF HEMI-VERTEBRA, COSTAL ANOMALIES, CHIARI MALFORMATION, 2 UNDESCENDED TESTES IN THE INGUINAL CANALS, A SLIGHTLY ENLARGED HEART, AN ATRIAL SEPTAL DEFECT, VENTRICULAR SEPTAL DEFECT, AORTIC STENOSIS, TRUNCUS ARTERIOSUS, QUADRICUSPID AORTIC VALVE, AND BILATERAL INFILTRATES IN THE LUNGS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR ECPC. THROUGH THE DURA, A TYPICALLY APPEARING LARGE SUBDURAL FLUID COLLECTION WAS OBSERVED. TWO SUTURES WERE PLACED WITH NUROLON 4-0 (ETHICON) TO SECURE THE ARACHNOID LAYER TO THE DURA TO PREVENT COLLAPSE OF THE ARACHNOID. UPON SLIGHTLY WITHDRAWING THE ENDOSCOPE TO GAIN AN ANGLE TO VISUALIZE THE LEFT CHOROID PLEXUS, THE ENDOSCOPIC VIEW BECAME VERY DARK DESPITE A FUNCTIONING LIGHT. BY VISUALIZING THE ENDOSCOPE WITH LOUPES, IT WAS APPARENT THAT THE ARACHNOID LAYER WAS LYING ON THE ENDOSCOPE. AT THIS POINT THE ARACHNOID EDGES BEGAN BLEEDING AND COULD NOT BE CONTROLLED WITH THE ENDOSCOPE. AN ULTRASOUND CLEARLY DEMONSTRATED ARACHNOID COLLAPSE. THE ENDOSCOPIC APPROACH WAS ABANDONED AND A MICROSCOPE WAS UTILIZED. HEMOSTASIS WAS OBTAINED WITH THE USE OF THE MICROSCOPE. IT WAS REPORTED THAT IN THIS CASE, THE ARACHNOID WAS SUTURED TO THE DURA AS A PREVENTATIVE MEASURE, BUT ARACHNOID COLLAPSE STILL OCCURRED. DUE TO THIS PROLONGED SURVIVAL POTENTIAL, WAITING TO PERFORM THE ECPC UNTIL THE CHILD HAS FURTHER DEVELOPED MAY REDUCE THE RISK OF ARACHNOID COLLAPSE BECAUSE OF THE EXPECTED INCREASED ADHERENCE OF THE ARACHNOID TO THE DURA. DESPITE THE OUTCOME REPORTED IN THIS CASE, PREVIOUS STUDIES CLEARLY DEMONSTRATE THAT ECPC SHOULD CONTINUE TO BE UTILIZED AS THE PREFERRED METHOD OF TREATMENT FOR PATIENTS WITH HYDRANENCEPHALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839158 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention