BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 18607993 · Received January 30, 2024

    Report

    Report Number
    2029214-2024-00196
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    January 12, 2024
    Report Date
    January 30, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: MURAOKA, S., ASAI, T., HAMASAKI, H., FUKUI, T., SUZUKI, N., NISHIZAWA, T., ARAKI, Y., & SAITO, R. DELAYED LEUKOENCEPHALOPATHY FOLLOWING NON-COIL EMBOLIZATION FLOW DIVERTER STENT DEPLOYMENT FOR AN INTRACRANIAL ANEURYSM. NEURORADIOLOGY: A JOURNAL DEDICATED TO NEUROIMAGING AND INTE JANUARY:1-3 2024. DOI:10.1007/S00234-024-03281-7 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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. 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

    MURAOKA S, ASAI T, HAMASAKI H, ET AL. DELAYED LEUKOENCEPHALOPATHY FOLLOWING NON-COIL EMBOLIZATION FLOW DIVERTER STENT DEPLOYMENT FOR AN INTRACRANIAL ANEURYSM. NEURORADIOLOGY: A JOURNAL DEDICATED TO NEUROIMAGING AND INTERVENTIONAL NEURORADIOLOGY. JANUARY 2024:1-3. DOI:10.1007/S00234-024-03281-7 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO EXAMINE DELAYED LEUKOENCEPHALOPATHY AS A POSTOPERATIVE COMPLICATION AFTER THE USE OF FLOW DIVERTER (FD) DEVICES FOR ENDOVASCULAR CEREBRAL ANEURYSM TREATMENT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - DESPITE EARLY POSTOPERATIVE MRI SHOWING MICROINFARCTIONS IN THE LEFT HEMISPHERE WITHOUT NEUROLOGICAL DEFICITS, THE PATIENT EXPERIENCED INTERMITTENT HEADACHES AND MEMORY DISTURBANCES 3 MONTHS POST-PROCEDURE. FURTHER IMAGING INDICATED MULTIPLE POST-CONTRAST T1-ENHANCING FOCI AND WIDESPREAD T2 HYPERINTENSE SIGNAL ABNORMALITIES IN THE LEFT CEREBRAL HEMISPHERE, SUGGESTING POTENTIAL EMBOLI OR FOREIGN BODY REACTIONS. THE PATIENT¿S CLOPIDOGREL REGIMEN WAS SWITCHED TO PRASUGREL DUE TO CONCERNS OVER THEIR CYP2C19 METABOLIZER STATUS. SUBSEQUENT APHASIA LED TO HOSPITAL READMISSION, WHERE MRI AND MR ANGIOGRAPHY IDENTIFIED WORSENING T2 HYPERINTENSE SIGNAL ANOMALIES, BUT NO NEW ISCHEMIC LESIONS. DELAYED LEUKOENCEPHALOPATHY WAS SUSPECTED AS THE CAUSE. THE PATIENT UNDERWENT STEROID PULSE THERAPY, RESULTING IN SIGNIFICANT IMPROVEMENT OF SPEECH AND WRITING DIFFICULTIES. FOLLOW-UP MRI SHOWED A SUBSTANTIAL DECREASE IN T2 SIGNAL ABNORMALITIES, AND CONTINUED IMPROVEMENT ALLOWED FOR THE TAPERING AND CESSATION OF ORAL STEROIDS. AT A 6-MONTH FOLLOW-UP, MRI CONFIRMED COMPLETE RESOLUTION OF THE SIGNAL ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251152 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H