BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 7912168 · Received September 26, 2018

    Report

    Report Number
    2021898-2018-00472
    Event Type
    Injury
    Date Received
    September 26, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHRISTINE K. LEE, TARA MOKHTARI, IAN D. CONNOLLY, GORDON LI, LAWRENCE M. SHUER, STEVEN D. CHANG, GARY K. STEINBERG, MELANIE HAYDEN GEPHART. COMPARISON OF PORCINE AND BOVINE COLLAGEN DURAL SUBSTITUTES IN POSTERIOR FOSSA DECOMPRESSION FOR CHIARI I MALFORMATION IN ADULTS. WORLD NEUROSURGERY 108 (2017). DOI: 10.1016/J.WNEU.2017.08.061 BACKGROUND: POSTERIOR FOSSA DECOMPRESSION SURGERIES FOR CHIARI MALFORMATIONS ARE SUSCEPTIBLE TO POSTOPERATIVE COMPLICATIONS SUCH AS PSEUDOMENINGOCELE, EXTERNAL CEREBROSPINAL FLUID (CSF) LEAK, AND MENINGITIS. VARIOUS DURAL SUBSTITUTES HAVE BEEN USED TO IMPROVE SURGICAL OUTCOMES. OBJECTIVE: THIS STUDY EXAMINED WHETHER THE COLLAGEN MATRIX DURAL SUBSTITUTE TYPE CORRELATED WITH THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AFTER POSTERIOR FOSSA DECOMPRESSION IN ADULT PATIENTS WITH CHIARI I MALFORMATIONS. METHODS: A RETROSPECTIVE COHORT STUDY WAS CONDUCTED OF 81 ADULT PATIENTS WHO UNDERWENT AN ELECTIVE DECOMPRESSIVE SURGERY FOR TREATMENT OF SYMPTOMATIC CHIARI I MALFORMATIONS, WITH DURAPLASTY INVOLVING A DURAL SUBSTITUTE DERIVED FROM EITHER BOVINE OR PORCINE COLLAGEN MATRIX. DEMOGRAPHICS AND TREATMENT CHARACTERISTICS WERE CORRELATED WITH SURGICAL OUTCOMES. RESULTS: A TOTAL OF 81 PATIENTS WERE INCLUDED IN THE STUDY. COMPARED WITH BOVINE DURAL SUBSTITUTE, PORCINE DURAL SUBSTITUTE WAS ASSOCIATED WITH A SIGNIFICANTLY HIGHER RISK OF PSEUDOMENINGOCELE OCCURRENCE (ODDS RATIO, 5.78; 95% CONFIDENCE INTERVAL, 1.65E27.15; P [ 0.01) AND A HIGHER OVERALL COMPLICATION RATE (ODDS RATIO, 3.70; 95% CONFIDENCE INTERVAL, 1.23E12.71; P[0.03) BY UNIVARIATE ANALYSIS. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE RATE OF MENINGITIS, REPEAT OPERATIONS, OR OVERALL COMPLICATION RATE BETWEEN THE 2 DURAL SUBSTITUTES. IN ADDITION, ESTIMATED BLOOD LOSS WAS A SIGNIFICANT RISK FACTOR FOR MENINGITIS (P [ 0.03). MULTIVARIATE ANALYSES AGAIN SHOWED THAT PORCINE DURAL SUBSTITUTE WAS ASSOCIATED WITH PSEUDOMENINGOCELE OCCURRENCE, ALTHOUGH THE ASSOCIATION WITH HIGHER OVERALL COMPLICATION RATE DID NOT REACH SIGNIFICANCE. CONCLUSIONS: DURAL SUBSTITUTES GENERATED FROM PORCINE COLLAGEN, COMPARED WITH THOSE FROM BOVINE COLLAGEN, WERE ASSOCIATED WITH A HIGHER LIKELIHOOD OF PSEUDOMENINGOCELE DEVELOPMENT IN ADULT PATIENTS UNDERGOING CHIARI I MALFORMATION DECOMPRESSION AND DURAPLASTY. REPORTED EVENTS. POSTOPERATIVE COMPLICATIONS OCCURRED IN 3 PATIENTS WHOM HAD ASEPTIC MENINGITIS. THE ASEPTIC MENINGITIS WAS ASSESSED BY PERSISTENT SYMPTOMS OF MENINGISMUS, FEVER, HEADACHE, BUT WITH NEGATIVE CSF CULTURE/GRAM STAIN OR LUMBAR PUNCTURE NOT PERFORMED TWO OF THE 3 PATIENTS WITH ASEPTIC MENINGITIS ALSO HAD PSEUDOMENINGOCELES. THE PSEUDOMENINGOCELE WAS ASSESSED BY CLINICALLY APPARENT AND RADIOGRAPHICALLY CONFIRMED PSEUDOMENINGOCELE DISCOVERED BECAUSE OF SYMPTOMS SUCH AS HEADACHES OR NECK STIFFNESS. THESE PATIENTS WITH PSEUDOMENINGOCELE RECOVERED WITHOUT FURTHER COMPLICATIONS AFTER NONOPERATIVE MANAGEMENT WITH STEROIDS. POSTOPERATIVE COMPLICATIONS OCCURRED IN 1 PATIENT WHOM HAD POSSIBLE BACTERIAL MENINGITIS, WITH AN EQUIVOCAL RESULT OF GRAM-POSITIVE COCCI IN CSF FROM LUMBAR PUNCTURE. THIS PATIENT RECOVERED WITHOUT FURTHER COMPLICATIONS AFTER INTRAVENOUS ANTIBIOTICS. ONE PATIENT WITH A PSEUDOMENINGOCELE (CLINICALLY APPARENT AND RADIOGRAPHICALLY CONFIRMED PSEUDOMENINGOCELE DISCOVERED BECAUSE OF SYMPTOMS SUCH AS HEADACHES OR NECK STIFFNESS) SUBSEQUENTLY DEVELOPED EVIDENCE OF HYDROCEPHALUS AND UNDERWENT PLACEMENT OF A VENTRICULOPERITONEAL SHUNT; THIS WAS THE ONLY OCCURRENCE OF A REPEAT OPERATION FOR ANY CAUSE. IN THE ARTICLE, IT WAS STATED THAT 36 OUT OF 42 PATIENTS WERE IMPLANTED WITH THE MANUFACTURER'S DEVICE; HOWEVER, IT WAS NOT INDICATED AND WAS UNCLEAR WHETHER OR NOT THE COMPLICATIONS INVOLVED THE MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751532 DUREPAIR DURA SUBSTITUTE DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN-D UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R