BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE PLATINUM

    MDR report key: 8955335 · Received September 3, 2019

    Report

    Report Number
    2029214-2019-00890
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 19, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K161879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE SOLITAIRE STENT WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE SITE; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SOLITAIRE STENT DETACHED DURING PULLING BACK THROUGH THE IMPLANTED STENT. IT WAS REPORTED THAT CAROTID STENT WAS IMPLANTED IN CAROTID ARTERY STENTING (CAS) TREATMENT. AS IT WAS UNCLEAR IN THE DISTAL SIDE, ANOTHER STENT WAS IMPLANTED. IMMEDIATELY AFTER, AS THROMBUS SILHOUETTE WAS NOTED ON THE DISTAL SIDE, AND THROMBUS WAS REMOVED WITH SOLITAIRE FR DEVICE (SFR). AFTER SFR WAS PLACED, IMMEDIATE FLOW RESTORATION WAS ACHIEVED, AND WHEN RECOVERING IT, THE SFR WAS CAUGHT ON THE CAS STENT EDGE, AND WHEN CONTINUING PULLING IT WITHOUT ANY ACTION, THE SFR STENT DETACHED. THE STENT WAS REMOVED WITH SNARE RETRIEVAL DEVICE AND DISCARDED. THERE WAS NOT ANY PATIENT INJURY REPORTED. THE VESSEL WAS MODERATELY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749003 SOLITAIRE PLATINUM CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR3-4-20-05 A770440

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention