BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 14743805 · Received June 20, 2022

    Report

    Report Number
    2029214-2022-01026
    Event Type
    Injury
    Date Received
    June 20, 2022
    Date of Event
    January 26, 2019
    Report Date
    November 14, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K123378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GELENER P, AKPINAR SH. RESTORATION OF A STENT-ASSISTED THROMBECTOMY-RELATED MIDDLE CEREBRAL ARTERY STENOSIS: A CASE WITH 3 YEARS¿ FOLLOW-UP. NEUROL SCI NEUROPHYSIOL 2019; 36(3): 171-3. DOI: 10.5152/NSN.2019.11669.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 · 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.

    Description of Event or Problem · 0

    GELENER P, AKPINAR SH. RESTORATION OF A STENT-ASSISTED THROMBECTOMY-RELATED MIDDLE CEREBRAL ARTERY STENOSIS: A CASE WITH 3 YEARS¿ FOLLOW-UP. NEUROL SCI NEUROPHYSIOL 2019; 36(3): 171-3. DOI: 10.5152/NSN.2019.11669. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A SOLITAIRE DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO REPORT THE CASE OF RESTORATION OF PROGRESSIVE STENT-ASSISTED THROMBECTOMY (SAT)-RELATED MIDDLE CEREBRAL ARTERY (MCA) STENOSIS IN COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) AFTER THREE YEARS FOLLOW-UP. COMPLETE RECANALIZATION OF TICI 3 WAS OBTAINED IN THE LEFT MCA AFTER FOUR PASSES OF SAT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: - DURING THE THROMBECTOMY PROCEDURE, A FOCAL 1-CM¿LONG INTERNAL CAROTID ARTERY (ICA) DISSECTION OCCURRED AT THE DISTAL CERVICAL ICA WHERE THE BALLOON GUIDING CATHETER WAS INFLATED. THE PATIENT WAS DISCHARGED WITH MRS 1 ON THE 7TH DAY. AT THE EARLY FOLLOW-UP OF HER ICA CERVICAL SEGMENT DISSECTION, DURING THE 8TH-WEEK FOLLOW-UP MAGNETIC RESONANCE ANGIOGRAPHY (MRA), SHEWAS DIAGNOSED AS HAVING FOCAL DISTAL MCA-M1 STENOSIS, WHICH PROGRESSED TO SIGNIFICANT STENOSIS (70+%) AT THE SAT SITE. AT THE ANNUAL FOLLOW-UP UNDER DUAL ANTIPLATELET TREATMENT (CLOPIDOGREL AND ASPIRIN), THE STENOSIS OF THE MCA WHERE THE SAT WAS PERFORMED WAS PROGRESSIVE AND IT HAD REACHED A CRITICAL LEVEL OF 90%. ALTHOUGH SHE WAS PUT ON DUAL ANTIPLATELET TREATMENT, INITIALLY FOR THE NON-OCCLUSIVE ICA DISSECTION, IT WAS NOT ENOUGH TO PREVENT ICA OCCLUSION, BUT THE MCA FLOW WAS RESTORED AS A RESULT OF A PATENT ANTERIOR COMMUNICATING ARTERY AND POSTERIOR COMMUNICATING ARTERY. CLOPIDOGREL WAS STOPPED AFTER TWO YEARS FOLLOW-UP BECAUSE HER CLINICAL STATUS WAS STABLE, BUT THIS RESULTED IN A MINOR STROKE ATTACK. CONSEQUENTLY, SHE WAS FOLLOWED UNDER DUAL ANTIPLATELET TREATMENT AND THE 3RD-YEAR FOLLOW-UP UNEXPECTEDLY SHOWED NEAR-TOTAL RESTORATION OF THE MCA STENOSIS. AS A RESULT, THE PRESENTED PATIENT HAD NO STENOSIS OR ATHEROSCLEROSIS IN THE MCA DURING AND IMMEDIATELY AFTER SAT; HOWEVER, SHE DEVELOPED M1 STENOSIS THAT WAS OBSERVED ON THE 63RD DAY, WHICH REACHED UP TO 70-75% AT THE 6TH MONTH AND WAS RESOLVED IN THE THIRD YEAR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ADVERSE EVENTS WERE NOT DIRECTLY RELATED TO ANY OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2869451 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR2-6-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other