BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 11396585 · Received March 1, 2021

    Report

    Report Number
    2029214-2021-00222
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    April 1, 2020
    Report Date
    March 1, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HO JUN YI, JAE HOON SUNG, DONG HOON LEE, SEUNG YOON SONG. EFFECTIVENESS AND TECHNICAL CONSIDERATIONS OF SOLITAIRE PLATINUM 4X40 MM STENT RETRIEVER IN MECHANICAL THROMBECTOMY WITH SOLUMBRA TECHNIQUE. JOURNAL OF KOREAN NEUROSURGICAL SOCIETY. 2021;64(1):30-38. DOI:10 .3340/JKNS.2020.0046. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HO JUN YI, JAE HOON SUNG, DONG HOON LEE, SEUNG YOON SONG. EFFECTIVENESS AND TECHNICAL CONSIDERATIONS OF SOLITAIRE PLATINUM 4X40 MM STENT RETRIEVER IN MECHANICAL THROMBECTOMY WITH SOLUMBRA TECHNIQUE. JOURNAL OF KOREAN NEUROSURGICAL SOCIETY. 2021;64(1):30-38. DOI:10 .3340/JKNS.2020.0046 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS EVALUATE THE EFFECT OF SOLITAIRE PLATINUM 4×40 MM STENT RETRIEVER IN SOLUMBRA TECHNIQUE THROMBECTOMY (STENT RETRIEVER WITH SIMULTANEOUS ASPIRATION), AND COMPARE IT WITH SHORTER SOLITAIRE STENT RETRIEVERS WITH EQUAL DIAMETER (4 MM) AND DIFFERENT LENGTH (40 VS. 20 MM) SOLITAIRE STENT RETRIEVERS: THE SOLITAIRE PLATINUM 4×40 MM STENT (4×40) AND THE SOLITAIRE FR 4×20 MM STENT OR SOLITAIRE PLATINUM 4×20 MM STENT. THE AUTHORS REVIEWED 70 CASES OF PATIENTS WHO UNDERWENT SOLUMBRA TECHNIQUE THROMBECTOMY. OF THE 70 PATIENTS, THE AVERAGE AGE WAS 70 YEARS, 29 WERE FEMALE AND 41 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED FOR THE 4X40 SOLITAIRE: 1. POST-THROMBECTOMY HEMORRHAGE (2 PATIENTS), SYMPTOMATIC HEMORRHAGE (1 PATIENT), DISTAL EMBOLI (2 PATIENTS), HEMORRHAGIC TRANSFORMATION OF INFARCTION (4 PATIENTS) SEE LITERATURE ARTICLE REFER TO MANUFACTURER REPORT 2029214-2021-00220 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290722 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention