BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 21851536 · Received April 16, 2025

    Report

    Report Number
    9612501-2025-01059
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 16, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    HANQIAO LI, JOHN CAIRD. VENTRICULO-PLEURAL SHUNT ¿ A SECOND LINE OPTION IN THE MANAGEMENT OF COMPLEX HYDROCEPHALUS. THE SURGEON. DOI: 10.10163/J.SURGE.2025.02.006. A B S T R A C T BACKGROUND: VENTRICULO-PLEURAL (V-PL) SHUNT IS CONSIDERED AS AN ALTERNATIVE MANAGEMENT OF HYDROCEPHALUS WHEN PREVIOUS MANAGEMENT OPTIONS OF HYDROCEPHALUS, INCLUDING VENTRICULOPERITONEAL (VP) SHUNT, VENTRICULO-ATRIAL (VA) SHUNT AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), MAY BE CONTRAINDICATED OR HAVE FAILED. AIM: THE AIM IS TO IDENTIFY THE INDICATIONS OF V-PL SHUNT AFTER THE FAILURE OF FIRST-LINE MANAGEMENTS OF HYDROCEPHALUS, TO EVALUATE THE EFFICACY OF V-PL SHUNT WITH REGARDING TO OTHER SHUNT OPTIONS AND TO DISCUSS THE POTENTIAL COMPLICATIONS. METHODS: 15 PATIENTS WHO UNDERWENT V-PL SHUNT (OR V-PL SHUNT RELATED SURGERIES) FROM 2021 TO 2024, ARE RECORDED RETROSPECTIVELY. THE DATA WAS COLLECTED VIA PATIENTS¿ MEDICAL CHARTS AND NATIONAL IMAGE ARCHIVING SYSTEM (REPUBLIC OF IRELAND). RELATED LITERATURE AND CASE REPORTS WERE SEARCHED VIA KEYWORD SELECTIONS ON RESEARCH DATABASES, INCLUDING PUBMED AND GOOGLE SCHOLAR. RESULTS: THE INDICATIONS FOR SHUNT TREATMENT WERE SPINA BIFIDA, TUMOUR RELATED HYDROCEPHALUS, CONGENITAL HYDROCEPHALUS, ARACHNOID CYSTS AND IDIOPATHIC INTRACRANIAL HYPERTENSION. INDICATIONS FOR FAVOURING V-PL SHUNT OVER VP/VA SHUNT OR ETV ARE MULTIPLE SHUNT FAILURES, PERSISTENT SHUNT-RELATED SYMPTOMS, SEVERE KYPHOSCOLIOSIS, ABDOMINAL ASCITES/PSEUDOCYST, JUGULAR VEIN THROMBOSIS. COMPLICATIONS OF V-PL SHUNT INCLUDE SHUNT FAILURE, OVERDRAINAGE, PLEURITIC CHEST PAIN, PNEUMOTHORAX AND RARELY SLIT-VENTRICLE SYNDROME. CONCLUSION: V-PL SHUNT CAN BE CONSIDERED AS A SECOND LINE MANAGEMENT FOR HYDROCEPHALUS WHEN VP/VA SHUNT AND ETV OPTIONS HAVE BEEN EXHAUSTED. REPORTED EVENTS - PATIENT 1 REQUIRED MULTIPLE SHUNT REVISIONS DUE TO RECURRENT SHUNT FAILURES; PATIENT 1 ALSO DEVELOPED PLEURITIC CHEST PAIN REQUIRING EXTERNALISATION OF SHUNT CATHETER. - PATIENT 14 REQUIRED MULTIPLE SHUNT REVISIONS DUE TO RECURRENT SHUNT FAILURES. - PATIENT 15 REQUIRED A SHUNT REVISION DUE TO VENTRICULAR CATHETER MALFUNCTION. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113838 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention