BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 502248 · Received December 19, 2003

    Report

    Report Number
    1063481-2003-00092
    Event Type
    Other
    Date Received
    December 19, 2003
    Date of Event
    November 19, 2003
    Report Date
    November 21, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH HISTORY OF LUMBAR SPONDYLOLISTHESIS UNDERWENT FUSION AND LAMINECTOMY PROCEDURE (NOT AN APPROVED INDICATION IN THE UNITED STATES) IN 2003. DURING THE SURGERY, A SMALL DURAL TEAR WAS ENCOUNTERED IN THE LUMBAR REGION OF THE PT'S BACK. BIOGLUE SURGICAL ADHESIVE WAS APPLIED FOLLOWING APPLICATION OF DURAGEN. THE AMOUNT OF SURGICAL ADHESIVE (BIOGLUE) USED, AS DESCRIBED BY THE ATTENDING SURGEON, WAS "ENOUGH TO FILL UP THE SPACE." SUBSEQUENT CORRESPONDENCE WITH THE RESIDENT PRESENT DURING THE SURGERY INDICATES THAT THE ENTIRE 10 ML CARTRIDGE WAS USED. AT APPROXIMATELY 36 HOURS AFTER SURGERY, THE PT DEVELOPED NUMBNESS IN THEIR LEFT FOOT AND LEG PAIN. CT SCAN SHOWED A EPIDURAL MASS AND THE PT RETURNED FOR REPEATED SURGERY THE NEXT DAY. A HARD MASS OF POLYMERIZED BIOGLUE WAS REMOVED DURING THE PROCEDURE FROM THE ORIGINAL SURGICAL SITE, WHICH APPEARED TO BE COMPRESSING ONE OR MORE SPINAL NERVES. IT IS REPORTED THAT THE PT APPEARS TO BE DOING BETTER FOLLOWING THE SECOND PROCEDURE. BASED ON THE INFO PROVIDED BY THE SURGEONS INVOLVED IN THIS CASE, FACTORS CONTRIBUTING TO THE ADVERSE OUTCOME INCLUDE: USE IN AN UNAPPROVED CLINICAL SETTING; APPLICATION OF AN EXCESSIVE AMOUNT OF THE PRODUCT RESULTING IN THE ACCUMULATION OF A LARGE COMPRESSIVE MASS; APPLICATION OF THE PRODUCT UNDER CONDITIONS WHERE COMPLETE VISUALIZATION OF ITS DEPOSITION WAS NOT POSSIBLE; AND FAILURE TO PRIME THE UNIT LEADING TO A POTENTIAL IMPROPER MIXING OF THE PRODUCT PRIOR TO APPLICATION. THIS INVESTIGATION IS ONGOING. ANY ADDITIONAL INFO THAT IS PROVIDED TO THE MANUFACTURER WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MFI CRYOLIFE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| R NOT AVAILABLE