BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 13468190 · Received February 7, 2022

    Report

    Report Number
    2029214-2022-00166
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    July 25, 2018
    Report Date
    February 6, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHMENTS FOR ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    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

    MARIO MARTI´NEZ-GALDA´MEZ, JORGE ESCARTI´N, BORIS PABO´N, CARLOS DIAZ, ROBERTO MARTI´N-REYES, ANTONIO HERMOSI´N, EDUARDO CRESPO, CLAUDIO RODRI´GUEZ, GONZALO MONEDERO, KRISHNA JOSHI, AND DEMETRIUS K LOPES; INTERVENTIONAL NEURORADIOLOGY; 2019; 25(2) 150¿156; OPTICAL COHERENCE TOMOGRAPHY: TRANSLATION FROM 3D-PRINTED VASCULAR MODELS OF THE ANTERIOR CEREBRAL CIRCULATION TO THE FIRST HUMAN IMAGES OF IMPLANTED SURFACE MODIFIED FLOW DIVERTERS; DOI: 10.1177/1591019918808466. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT A PIPELINE WAS MISPLACED AND FAILED TO OPEN COMPLETELY.  A PATIENT IS HIS SIXTIES CONSULTED BECAUSE OF RECURRENT HEADACHES. TABLET CLOPIDOGREL 75MG/DAY AND ASPIRIN 100MG/DAY WERE STARTED ONE WEEK PRIOR TO THE INTERVENTION. A 4 20MM PIPELINE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY WAS SELECTED BASED ON THE MAXIMUM PARENT ARTERY DIAMETER. OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGE SERIES (540 FRAMES COVERING 54MM VESSEL LENGTH, 10 MM/S PULLBACK SPEED) WERE TAKEN ALONG THE PARENT ARTERY AND ACROSS THE NECK OF THE ANEURYSM. OCT IMAGES SHOWED THAT PIPELINE SHIELD FULLY EXPANDED TO NOMINAL AT THE PARACLINOID AND CAVERNOUS SEGMENTS. FOUND DISCORDANCE WITH DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) ARTERY MEASUREMENTS, RESULTING IN AREAS OF MALAPPOSITION DESPITE NOMINAL OPENING, ESPECIALLY AT THE PARACLINOID PORTION. NO THROMBUS WAS IDENTIFIED ON THE DEVICE SURFACE. AREAS OF MALAPPOSITION AND FAILURE OF THE DEVICE TO FULLY OPEN WERE FOUND CLOSE TO THE ANEURYSM NECK, BUT THIS ISSUE DID NOT AFFECT CONTRAST STASIS. NO ADDITIONAL ACTION WERE TAKEN. HE CONTINUED ON A DUAL ANTIPLATELET REGIMEN (ALTERNATE-DAY CLOPIDOGREL 75 MG AND DAILY ASPIRIN 100 MG), TO BE MAINTAINED FOR THE NEXT THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505674 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-PED2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male