BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7814384 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00078
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    July 31, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED IN THE RETROSPECTIVE REVIEW FROM MAY 2009 TO JUNE 2013, IT IS NOT POSSIBLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, IT WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND EVENT/NC/CAPA/SCAR HISTORY REVIEW. THE STUDY IS NOT CONCLUSIVE OF RELATING THE REPORTED CONDITIONS WITH DURAGEN PRODUCTS. THUS, THE ROOT CAUSE OF THE REPORTED CONDITION IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS CAN ALSO BE FOUND ONLINE AT : DOI HTTP://DX.DOI.ORG/10.1055/S-0035-1568871.

    Description of Event or Problem · 1

    JOURNAL OF NEUROLOGICAL SURGERY-PART B (2016) PUBLISHED, " ENDOSCOPIC ENDONASAL RECONSTRUCTION OF SKULL BASE: REPAIR PROTOCOL". THE STUDY AIMS TO DECREASING THE OVERALL POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAK RATE. METHODS: A RETROSPECTIVE REVIEW OF PROSPECTIVELY RECORDED DATA FOR 180 CONSECUTIVE EERS FROM MAY 2009 TO JUNE 2013 WAS CONDUCTED. ENDOSCOPIC ENDONASAL RECONSTRUCTIONS WERE GRADED I TO IV BASED ON ACTUAL RECONSTRUCTION PERFORMED. THE CHOICE OF RECONSTRUCTION TYPES I TO III WAS DETERMINED INTRAOPERATIVELY BASED ON SEVERITY OF ANY CSF LEAKS. TYPE IV REPAIRS INCLUDED A HARVESTED NSF AND THEREFORE WERE PLANNED PREOPERATIVELY. TYPE IV RECONSTRUCTIONS INCLUDED A POSTERIOR NASAL SEPTAL FLAPS (NSF), HARVESTED AT THE BEGINNING OF THE PROCEDURE. AN APPROPRIATE SIZE DURAGEN WAS USED AS INLAY. FAT GRAFT AND ALLODERM WERE THEN ADDED, AND THE NSF WAS PLACED OVER THE SELLA, COVERING THE ALLODERM AND ANTERIOR SKULL BASE WITH THE MUCOSAL SIDE FACING OUT. EVICEL AND GELFOAM WERE THEN LAYERED OVER THE NSF TO BUTTRESS IT IN PLACE. A 14F FOLEY CATHETER WAS USED TO KEEP THE RECONSTRUCTION IN PLACE FOR 24 HOURS. RESULTS: THERE WERE TWO POSTOPERATIVE CSF LEAKS FOR TYPE IV RECONSTRUCTIONS USING DURAGEN. THE POSTOPERATIVE CSF LEAK RATE FOR TYPE III RECONSTRUCTIONS (18%) WAS GREATER THAN FOR ALL OF THE OTHER RECONSTRUCTIONS. THERE WAS A SIGNIFICANT OVERALL DIFFERENCE IN POSTOPERATIVE CSF LEAKS BETWEEN THE FOUR RECONSTRUCTION TYPES. PAIRWISE COMPARISON BETWEEN GROUPS REVEALED SIGNIFICANT DIFFERENCES IN POSTOPERATIVE CSF LEAK RATES BETWEEN GROUPS I AND II BETWEEN GROUPS I AND III ,AND BETWEEN RECONSTRUCTION TYPES III AND IV. THERE WERE 25 PATIENTS WHO REQUIRED LUMBAR DRAIN PLACEMENT IN THE PERIOPERATIVE PERIOD. OF THE TYPE IV REPAIRS, MOST WERE PLACED INTRAOPERATIVELY. CONCLUSION: A REPAIR PROTOCOL WHICH STRATIFIES PATIENTS BASED ON ANTICIPATED AND INTRAOPERATIVE CSF LEAKS HAS THE POTENTIAL TO MINIMIZE COST OF UNNECESSARY REPAIR MATERIALS, GRAFT HARVESTING MORBIDITY, AND LUMBAR CSF DIVERSION FOR PATIENTS WITH SMALLER OR NO CSF LEAKS, AND MAXIMIZE POSTOPERATIVE SUCCESS RATES. THE AUTHORS ADVOCATE A MORE GENEROUS USE OF TYPE IV RECONSTRUCTIONS WHEN ONE CAN ANTICIPATE A GREATER RISK OF HIGHER FLOW CSF LEAK OCCURRENCE. THEY ALSO ADVOCATE A MORE ROBUST RECONSTRUCTION FOR TYPE II LEAK BY PERFORMING A TYPE III RECONSTRUCTION AS THE 5% POSTOPERATIVE LEAK RATE IN TYPE II IS STILL RELATIVELY HIGH. ALTERNATIVELY, THE USE OF RESCUE FLAP AT THE END OF THE PROCEDURE FOR UNEXPECTED SIGNIFICANT CSF LEAK IS STRONGLY RECOMMENDED CONSIDERING THE HIGH RATE OF LEAK RATE IN TYPE III RECONSTRUCTION IT IS OBVIOUS THAT EXPERIENCE PLAYS A ROLE IN THIS DECISION-MAKING PROCESS, AS MORE TYPE IV RECONSTRUCTIONS, AND INTRAOPERATIVE PLACEMENT OF LD FOR TYPE III WERE UTILIZED TOWARD THE END OF THE PRESENT SERIES, WITH GREATER SUCCESS AND SIGNIFICANTLY LOWER POSTOPERATIVE CSF LEAK RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654836 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLODERM| EVICEL| FAT GRAFT| LUMBAR DRAIN| POSTERIOR NASOSEPTAL FLAP