BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUREPAIR®

    MDR report key: 17498547 · Received August 10, 2023

    Report

    Report Number
    2021898-2023-00056
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Report Date
    August 10, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    XU, RISHENG MD, PHD*; SO, RAYMOND J. AB*; MATERI, JOSHUA BS*; NAIR, SUMIL K. BA*; ALOMARI, SAFWAN O. MD*; HUANG, JUDY MD*; LIM, MICHAEL MD¿; BETTEGOWDA, CHETAN MD, PHD*. FACTORS PREDICTING CEREBROSPINAL FLUID LEAKS IN MICROVASCULAR DECOMPRESSIONS: A CASE SERIES OF 1011 PATIENTS. OPERATIVE NEUROSURGERY 24(3):P 262-267, MARCH 2023. / DOI: 10.1227/ONS.0000000000000503 BACKGROUND: MICROVASCULAR DECOMPRESSION (MVD) USING A RETROSIGMOID APPROACH IS A HIGHLY EFFECTIVE, OPEN-SURGICAL PROCEDURE FOR NEURO VASCULAR CONFLICT IN THE POSTERIOR FOSSA, ALTHOUGH THERE IS A RISK OF POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAK. OBJECTIVE: TO IDENTIFY FACTORS ASSOCIATED WITH POSTOPERATIVE CSF LEAKAGE AFTER MVD. METHODS: WE RETROSPECTIVELY REVIEWED ALL PATIENTS WHO UNDERWENT MVDS AT OUR INSTITUTION FROM 2007 TO 2020. PATIENT DEMOGRAPHICS, CLINICAL DIAGNOSES, AND PROCEDURAL CHARACTERISTICS WERE RECORDED AND COMPARED. FACTORS LEADING TO CSF LEAK WERE ANALYZED USING 2 , UNIVARIATE, AND MULTIVARIATE REGRESSION. RESULTS: OF 1011 PATIENTS WHO UNDERWENT MVDS, 37 (3.7%) PRESENTED WITH POSTOPERATIVE CSF LEAKS. IN UNIVARIATE ANALYSIS, THE USE OF C RANIOS/NORIAN TO OBLITERATE THE AIR CELLS WAS PROTECTIVE AGAINST CSF LEAK (P = .01). CRANIOTOMIES (P = .002), THE USE OF DURAL SUBSTITUTES SUCH AS DUREPAIR (P = .04), DURAL ONLAYS SUCH AS DURAGEN (P = .04), MUSCLE/FASCIA (P = .03), AND TITANIUM MESH CRANIOPLASTY >5 CM (P = .03) WERE ASSOCIATED WITH CSF LEAK. ON MULTIVARIATE ANALYSIS, ONLY THE PRESENCE OF CRANIOTOMIES (P = .04) AND NONPRIMARY DURAL CLOSURE (P = .03) WERE SIGNIFICANT RISK FACTORS FOR CSF LEAK. WHEN EXCLUDING THE 34 (3.4%) PATIENTS WHO UNDERWENT A CRANIOTOMY, THE LACK OF PRIMARY DURAL CLOSURE STILL REMAINED SIGNIFICANTLY ASSOCIATED WITH POSTOPERATIVE CSF LEAK (P = .04). CONCLUSION: OUR RESULTS REPRESENT ONE OF THE LARGEST SERIES OF POSTERIOR FOSSA SURGERIES FOR A UNIFORM INDICATION IN NORTH AMERICA. OUR STUDY DEMONSTRATES INCREASED RISK FOR POSTOPERATIVE CSFLEAK WHEN CRANIOTOMIES ARE PERFORMED AND WHEN PRIMARY DURAL CLOSURE IS NOT ESTABLISHED. GIVEN THE SMALL SAMPLE OF PATIENTS WHO RECEIVED A CRANIOTOMY, HOWEVER, FUTURE STUDIES CORROBORATING THIS FINDING SHOULD BE PERFORMED. EVENTS: IT WAS REPORTED THAT THERE WERE 7 CSF LEAKS ASSOCIATED WITH DURAREPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382754 DUREPAIR® DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown