BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 15715987 · Received November 2, 2022

    Report

    Report Number
    9612501-2022-01905
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 2, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: NO PARTS WERE 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.

    Description of Event or Problem · 0

    YAN-HUA SU ACTA NEUROCHIRURGICA 164: 459¿467 2021, MARCH 1ST, HTTPS://DOI.ORG/10.1007/S00701-021-04763-W ABSTRACT OBJECTIVE TO INVESTIGATE THE OUTCOMES OF CEREBROSPINAL FLUID (CSF) DIVERSION IN LUNG CANCER PATIENTS WITH LEPTOMENINGEAL CARCINOMATOSIS (LMC). METHODS A RETROSPECTIVE REVIEW OF CONSECUTIVE LUNG CANCER PATIENTS WITH LMC SUFFERING FROM INCREASED INTRACRANIAL PRESSURE (IICP) AND HYDROCEPHALUS BETWEEN FEBRUARY 2017 AND FEBRUARY 2020. WE EVALUATED THE SURVIVAL BENEFIT OF CSF DIVERSION SURGERY AND ASSESSED THE OUTCOMES OF TREATMENTS ADMINISTERED POST-LMC IN TERMS OF OVERALL SURVIVAL AND SHUNT-RELATED COMPLICATIONS. RESULTS THE STUDY COHORT INCLUDED 50 PATIENTS (MEDIAN AGE: 59 YEARS). VENTRICULAR PERITONEAL (VP) SHUNTS WERE PLACED IN 33 PATIENTS, AND LUM BAR PERITONEAL (LP) SHUNTS WERE PLACED IN 7 PATIENTS. PROGRAMMABLE SHUNTS WERE PLACED IN 36 PATIENTS. SHUNT ADJUSTMENT WAS PERFORMED IN 19 PATIENTS. KAPLAN-MEIER ANALYSIS REVEALED THAT SHUNT PLACEMENT INCREASED OVERALL SURVIVAL FROM 1.95 MONTHS TO 6.21 MONTHS (P = 0.0012) AND INCREASED KARNOFSKY PERFORMANCE SCORES (KPS) FROM 60 TO 70. UNIVARIATE ANALYSIS REVEALED NO DIFFERENCE BETWEEN VP OR LP SHUNTS IN TERMS OF SURVIVAL. NO DIFFERENCES IN POST-SHUNT SYSTEMIC TREATMENTS (TYROSINE KINASE INHIBITORS (TKIS) OR SYSTEMIC TREATMENTS) WERE OBSERVED IN OVERALL SURVIVAL. SHUNT-RELATED COMPLICATIONS WERE NOTED IN 7 PATIENTS, INCLUDING SHUNT OBSTRUCTION (N = 4), INFECTION (N = 1), AND OVER-DRAINAGE (N = 2). CONCLUSION CSF DIVERSION (VP OR LP SHUNT) APPEARS TO BE AN EFFECTIVE AND SAFE TREATMENT FOR LUNG CANCER PATIENTS WITH LMC AND HYDROCEPHALUS. PROGRAMMABLE SHUNTS SHOULD BE CONSIDERED FOR COMPLEX CASES, WHICH COMMONLY REQUIRE PRESSURE ADJUSTMENTS AS THE DISEASE PROGRESSES. SERIOUS INJURIES: AMONG THE 36 PATIENTS WHO RECEIVED PROGRAMMABLE VALVES, 19 UNDERWENT AT LEAST ONE SHUNT SETTING ADJUSTMENT WITHIN THE FIRST 2.5 MONTHS AFTER PLACEMENT. SOME PATIENTS UNDERWENT PRESSURE ADJUSTMENT UP TO 4 TIMES UNTIL PATIENT DECEASED. INFECTION WAS DETECTED IN 1 VP SHUNT PATIENT (2.5%), WHICH NECESSITATED MULTIPLE REVISION SURGERIES. SHUNT OBSTRUCTION WAS DETECTED IN 3 VP SHUNT PATIENTS AND 1 LP SHUNT PATIENT (10% OVERALL). TWO CASES OF OBSTRUCTION WERE TREATED USING REVISION SURGERY AND TWO UNDERWENT HOSPICE CARE. SYMPTOMS OF OVER-SHUNTING WERE OBSERVED IN 2 PATIENTS (5%), BOTH OF WHICH WERE CORRECTED BY ADJUSTING THE VALVE SETTINGS. TWO PATIENTS WERE SUSPECTED OF PERITONEAL METASTASIS; HOWEVER, THAT DIAGNOSIS WAS MADE PRIOR TO SHUNT PLACEMENT. NONE OF THE PATIENTS PRESENTED SYMPTOMS OF ASCITES AT THE TIME OF SHUNT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2913180 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention