BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 8380212 · Received February 28, 2019

    Report

    Report Number
    2021898-2019-00080
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KOICHI MITSUYA, YOKO NAKASU, NAKAMASA HAYASHI, SHOICHI DEGUCHI, TOSHIAKI TAKAHASHI, HARUYASU MURAKAMI, TATEAKI NAITO, HIROTSUGU KENMOTSU, AKIRA ONO, KAZUSHIGE WAKUDA, HIDEYUKI HARADA. PALLIATIVE CEREBROSPINAL FLUID SHUNTING FOR LEPTOMENINGEAL METASTASIS-RELATED HYDROCEPHALUS IN PATIENTS WITH LUNG ADENOCARCINOMA: A SINGLE-CENTER RETROSPECTIVE STUDY. PLOS ONE 14 (2019). DOI: 10.1371/JOURNAL.PONE.0210074 ABSTRACT PURPOSE: MANAGEMENT OF LEPTOMENINGEAL METASTASIS-RELATED HYDROCEPHALUS (LM-H) IS PARTICULARLY CHALLENGING REGARDING THE CONTROL OF SEVERE HEADACHE, NAUSEA, AND VOMITING DUE TO INTRACRANIAL HYPERTENSION. TO INVESTIGATE THE IMPROVEMENTS OF PERFORMANCE STATUS AND OUTCOME WITH CEREBROSPINAL FLUID (CSF) SHUNT SURGERY FOR LM-H IN PATIENTS WITH LUNG ADENOCARCINOMA. METHODS: DATA ON PATIENTS WITH LEPTOMENINGEAL METASTASIS-RELATED HYDROCEPHALUS FROM LUNG ADENOCARCINOMA DIAGNOSED BY MR IMAGING AND/OR CYTOLOGICAL EXAMINATION WERE RETROSPECTIVELY ANALYZED. BETWEEN AUGUST 2008 AND JULY 2017, THE AUTHORS REVIEWED 31 PATIENTS REQUIRING CSF SHUNT, WHO UNDERWENT VENTRICULO-PERITONEAL OR LUMBO-PERITONEAL SHUNT. RESULTS: THE PATIENTS CONSISTED OF 11 MEN AND 20 WOMEN WITH A MEDIAN AGE OF 59 YEARS. TWENTY-SIX PATIENTS RECEIVED EGFR-TYROSINE KINASE INHIBITORS (TKIS). CSF SHUNT SURGERY YIELDED RAPID IMPROVEMENT IN THE PERFORMANCE STATUS OF 90.3% OF PATIENTS. MEDIAN OVERALL SURVIVAL FROM THE DIAGNOSIS OF LM IN PATIENTS WITH ECOG PERFORMANCE STATUS LESS THAN 2 WAS 7.7 MONTHS, AND THIS WAS SIGNIFICANTLY LONGER THAN THOSE IN PATIENTS WITH PS 3 OR 4 (4.4 OR 1.5 MONTHS; P>0.001). MULTIVARIATE ANALYSIS BY COX REGRESSION REVEALED SURVIVAL DIFFERENCES ACCORDING TO PS AT DIAGNOSIS OF LM [PS 1¿3 VS. PS4, HAZARD RATIO (HR) 0.201, P = 0.034], CONTROLLED EXTRACRANIAL DISEASE (HR 0.248, P = 0.005), AND POST-SHUNT EGFR-TKI FOR LM TREATMENT (HR 0.193, P = 0.008). POSTOPERATIVE SYMPTOMATIC PERITONEAL CARCINOMATOSIS WAS OBSERVED IN ONE PATIENT (3.2%). CONCLUSION: CSF SHUNTING MAY BE A SAFE AND EFFECTIVE STRATEGY IN PATIENTS WITH LM-H FROM LUNG ADENOCARCINOMA. A PROSPECTIVE STUDY IS NEEDED TO ESTABLISH THE EFFECTIVENESS AND SAFETY OF PALLIATIVE CSF SHUNT FOR LM-H. REPORTED EVENTS. 1. ONE PATIENT SUFFERED FROM CATHETER DISPOSITION THAT NEEDED A REVISION SURGERY AFTER VP SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172571 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R