BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD PERICARDIUM WITH APEX PROCESSING

    MDR report key: 3092732 · Received May 3, 2013

    Report

    Report Number
    2032282-2013-00051
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    PMA / PMN Number
    K982282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS THE SECOND OF TWO PATIENTS REPORTED TO HAVE EXPERIENCED MENINGITIS FOLLOWING THE USE OF DURA-GUARD DURING THE CLINICAL STUDY ENTITLED "THE NEED IN DURAL GRAFT SUTURING IN CHIARI I MALFORMATION DECOMPRESSION: A PROSPECTIVE, SINGLE-BLIND, RANDOMIZED TRIAL COMPARING SUTURED AND SUTURELESS DURAPLASTY MATERIALS." ALTHOUGH MENINGITIS IS A COMMON COMPLICATION ASSOCIATED WITH POSTERIOR FOSSA DECOMPRESSION SURGERY FOR CHIARE I MALFORMATIONS, A CONTRIBUTION FROM THE USE OF DURA-GUARD CANNOT BE RULED OUT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. POST-OPERATIVE INFECTIONS, INCLUDING MENINGITIS, ARE A KNOWN COMPLICATION OF CHIARI I MALFORMATION DECOMPRESSION SURGERY. PER THE MEDICAL ASSESSMENT, CONTRIBUTION FROM THE DURA-GUARD PATCH CANNOT BE RULED OUT. THE LITERATURE IS NOT SPECIFIC REGARDING WHAT POST-OPERATIVE TREATMENT WAS REQUIRED BY THIS PATIENT; HOWEVER ON PAGE 3 OF 6 OF THE ARTICLE IT IS NOTED THAT THERE WERE NO READMISSIONS FOR THE PATIENTS THAT RECEIVED THE DURA-GUARD. PER SYNOVIS, ADDITIONAL INVESTIGATION IS NOT REQUIRED AS THE RISK ASSESSMENT DOCUMENTS INDICATE THAT THIS EVENT FALLS WITHIN ACCEPTABLE RISK PARAMETERS AND THIS IS A KNOWN COMPLICATION OF THE PROCEDURE. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    FROM LITERATURE: LEENA E WILLIAMS, PRASAD S, VANNEMREDDY, KARRIEM S. WATSON, AND KONSTANTIN V. SLAVIN (2013). THE NEED IN DURAL GRAFT SUTURING IN CHIARI I MALFORMATION DECOMPRESSION: A PROSPECTIVE, SINGLE-BLIND, RANDOMIZED TRIAL COMPARING SUTURED AND SUTURELESS DURAPLASTY MATERIALS. SURGICAL NEUROLOGY INTERNATIONAL (2013) 4:26. PUBLISHED ONLINE 2013 FEBRUARY 27. DOI: 104103/2152-7806.107904. SUMMARY OF ARTICLE FROM ABSTRACT: THIS STUDY FOCUSES ON POSTERIOR FOSSA DECOMPRESSION FOR THE TREATMENT OF CM I AND THE POSSIBLE BENEFITS OF SUTURED VS. SUTURELESS DURAPLASTY IN A SURGERY REQUIRING AN OPENING OF THE DURA MATER. THIRTY-FOUR PATIENTS WERE ENROLLED. AVERAGE AGE WAS 38.7 - 12.2 YEARS (MEAN SD (STANDARD DEVIATION)) AND 82% OF PATIENTS WERE FEMALE. SIXTEEN PATIENTS RECEIVED DURAGEN AND 18 DURA-GUARD. AGE AND GENDER WERE SIMILAR AMONG GROUPS. POSTOPERATIVE COMPLICATIONS DID NOT DIFFER BETWEEN GROUPS. AVERAGE QLQ SCORES AT MONTHS 1, 2, AND 3 IMPROVED IN BOTH GROUPS. DURA-GUARD PATIENTS SHOWED GREATER IMPROVEMENT IN QUALITY OF LIFE AT MONTH 2 (P < 0.05) BUT, GROUPS DID NOT DIFFER AT FINAL SURVEY. ALL PATIENT'S PHYSICAL HEALTH (P < 0.005) AND FUNCTION (P < 0.005) WERE SIGNIFICANTLY IMPROVED. OUTCOME DID NOT DIFFER BETWEEN GROUPS AND ALL PATIENTS SHOWED SIGNIFICANT IMPROVEMENT (P < 0.05). MENINGITIS PATIENT 2: UPON REVIEW OF THE ARTICLE, IT WAS IDENTIFIED TWO PATIENTS EXPERIENCED MENINGITIS. THIS IS ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194665 DURA-GUARD PERICARDIUM WITH APEX PROCESSING DURA SUBSTITUTE GXQ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other