BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812738 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00033
    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 · 1

    THE FAILURE ANALYSIS WAS NOT POSSIBLE BECAUSE THE COMPLAINT UNIT WILL NOT BE RETURNED FOR EVALUATION. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED DURING THE RETROSPECTIVE EVALUATION, IT IS UNABLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND EVENT/NC/CAPA/SCAR HISTORY REVIEW. THE REPORTED CONDITION IS UNCONFIRMED. ROOT CAUSE CANNOT BE NOT DETERMINED AT THIS TIME. DOI: 10.2500/AJRA.2016.30.4356

    Description of Event or Problem · 1

    AMERICAN JOURNAL OF RHINOLOGY & ALLERGY (2016) PUBLISHED "LAYERED SELLAR RECONSTRUCTION WITH AVASCULAR FREE GRAFTS: ACCEPTABLE ALTERNATIVE TO THE NASOSEPTAL FLAP FOR REPAIR OF LOW-VOLUME INTRAOPERATIVE CEREBROSPINAL FLUID LEAK" WHICH DESCRIBES A METHOD OF RECONSTRUCTION OF INTRAOPERATIVE CSF LEAK IN ENDOSCOPIC SURGERY OF THE SELLA TURCICA AND ANALYZE ITS POSTOPERATIVE SUCCESS RATE AND ASSOCIATED COMORBIDITIES. A RETROSPECTIVE REVIEW OF EXPANDED ENDONASAL SELLAR TUMOR RESECTIONS FROM 2008¿2014 WAS PERFORMED, AND CASES OF LAYERED INTRAOPERATIVE SKULL BASE RECONSTRUCTION WITH AVASCULAR FREE GRAFTS WERE IDENTIFIED. DEMOGRAPHIC FACTORS AND COMORBIDITIES THAT PREDISPOSED TO RECONSTRUCTION FAILURE (OBSTRUCTIVE SLEEP APNEA, OBESITY) WERE DETERMINED. RECONSTRUCTION-RELATED NASAL COMPLICATIONS WERE ALSO IDENTIFIED. POSTOPERATIVE CSF LEAK RATE WAS DETERMINED, AND STATISTICAL ANALYSIS WAS PERFORMED TO IDENTIFY PREDICTIVE FACTORS FOR RECONSTRUCTIVE FAILURE. ALL PATIENTS UNDERWENT RECONSTRUCTION OF THE SKULL BASE DEFECT IN A LAYERED FASHION. THE TYPICAL RECONSTRUCTION CONSISTED OF TWO DURAL GRAFTS, ONE UNDERLAYING THE DURA AND ONE OVERLAYING THE DURA BUT UNDERLAYING THE BONE, AS WELL AS A MUCOSAL OR SYNTHETIC GRAFT OVERLAYING THE SELLAR FLOOR OPENING. TO BEGIN THE RECONSTRUCTION, THE SITE OF CSF LEAKAGE WAS IDENTIFIED AND COVERED WITH GELFOAM (PFIZER, INC,). A DURAL UNDERLAY WAS THEN PERFORMED, TYPICALLY WITH A SYNTHETIC DURAL SUBSTITUTE (DURAGEN; INTEGRA LIFESCIENCES CORP.). A BONY UNDERLAY LAYER WAS THEN PLACED BETWEEN THE DURA AND THE EDGES OF THE SELLAR OPENING, TYPICALLY WITH A RESORBABLE COLLAGEN MATRIX (DURAMATRIX; STRYKER CORP.). IN CASES IN WHICH A BONY OVERLAY WAS PERFORMED, EITHER SYNTHETIC MATERIAL (ALLODERM; LIFECELL CORP.) OR A MIDDLE TURBINATE MUCOSAL AUTOGRAFT (MTMG) WAS USED. A SMALL AMOUNT OF TISSUE GLUE WAS TYPICALLY ADMINISTERED TO KEEP THE GRAFTS IN POSITION. THE RECONSTRUCTION WAS THEN COVERED WITH GELFOAM PLEDGETS AND SURGICEL (ETHICON INC, (B)(4)), AND SUPPORTED WITH INTRANASAL PACKING. LUMBAR DRAINAGE WAS NOT ROUTINELY PERFORMED IN THIS COHORT. RESULTS: THERE WERE A TOTAL OF 73 PATIENTS WHO HAD INTRAOPERATIVE CSF LEAKS RECONSTRUCTED WITH LAYERED AVASCULAR GRAFTS AFTER EXPANDED ENDONASAL ENDOSCOPIC RESECTION OF SELLAR LESIONS BETWEEN 2008 AND 2014. THERE WERE A TOTAL OF FIVE POSTOPERATIVE CSF LEAKS ENCOUNTERED (6.9%). THERE WERE FOUR POSTOPERATIVE LEAKS IN PATIENTS WITH NONFUNCTIONING PITUITARY ADENOMAS (8.5%) AND ONE POSTOPERATIVE LEAK IN A PATIENT WITH A CRANIOPHARYNGIOMA (100%). THE MEAN TIME FROM SURGERY TO PRESENTATION WITH A POSTOPERATIVE LEAK WAS 12 DAYS (RANGE 3-21 DAYS). TWO OF THESE PATIENTS WERE MANAGED CONSERVATIVELY WITH LUMBAR DRAINAGE WHEREAS THE REMAINING THREE WERE TAKEN BACK TO THE OPERATING ROOM FOR DEFINITIVE REPAIR. THERE WAS A SIGNIFICANTLY INCREASED RISK OF POSTOPERATIVE LEAK IN THOSE PATIENT NOTED TO HAVE HIGH-FLOW INTRAOPERATIVE LEAKS COMPARED WITH THOSE WITH LOW-FLOW LEAKS. CONCLUSION: IN CASES OF LOW-VOLUME INTRAOPERATIVE CSF LEAK, LAYERED SKULL BASE REPAIR WITH AVASCULAR FREE GRAFTS WAS AN ACCEPTABLE ALTERNATIVE TO THE NASOSEPTAL FLAP, WHICH MAY REDUCE PROLONGED SINONASAL HEALING AND DONOR-SITE MORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654533 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLODERM| DURAMATRIX| GELFOAM| GELFOAM PLEDGETS| MIDDLETURBINATE MUCOSAL AUTOGRAFT| SURGICEL| TISSUE GLUE