BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE

    MDR report key: 10624857 · Received October 5, 2020

    Report

    Report Number
    2029214-2020-00998
    Event Type
    Death
    Date Received
    October 5, 2020
    Date of Event
    May 22, 2013
    Report Date
    October 4, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. 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. REFER TO MANUFACTURER REPORT 2029214-2020-00997 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PEREIRA VM, GRALLA J, DAVALOS A, BONAFÉ A, CASTAÑO C, CHAPOT R, LIEBESKIND DS, NOGUEIRA RG, ARNOLD M, SZTAJZEL R, ET AL. PROSPECTIVE, MULTICENTER, SINGLE-ARM STUDY OF MECHANICAL THROMBECTOMY USING SOLITAIRE FLOW RESTORATION IN ACUTE ISCHEMIC STROKE. STROKE. 2013;44:2802¿2807. DOI: 10.1161/STROKEAHA.113.001232. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THE RESULTS OF A LARGE PROSPECTIVE STUDY ON THE USE OF THE SOLITAIRE FLOW RESTORATION IN PATIENTS WITH ACUTE ISCHEMIC STROKE. THE AUTHORS REVIEWED 202 CASES OF PATIENTS TREATED FOR LARGE VESSEL ANTERIOR CIRCULATION STROKES USING A SOLITAIRE STENT RETRIEVER. OF THE 202 PATIENTS, THE AVERAGE AGE WAS 72 YEARS, 60% WERE FEMALE AND 40% WERE MALE. THE RATE OF THE PRIMARY OUTCOME (SUCCESSFUL REVASCULARIZATION [TICI=2B] AFTER =3 PASSES OF THE STUDY DEVICE AS ADJUDICATED BY INDEPENDENT CORE LABORATORY EVALUATION) WAS 79.2% (160/202). IN 42 PATIENTS (20.8%), TICI=2B WAS NOT ACHIEVED WITHIN THE LIMITED NUMBER OF 3 PASSES (DEVICE TREATMENT FAILURES), IN 18 OF THESE (9%) RESCUE THERAPY WAS PERFORMED. ADDITIONAL TREATMENT CONSISTED OF INTRA-ARTERIAL THROMBOLYSIS IN 2 PATIENTS, MT IN 13 PATIENTS. IN 3 PATIENTS, COMBINED INTRAARTERIAL THROMBOLYSIS AND MT WAS PERFORMED. AFTER RESCUE THERAPY, CORE LABORATORY DETERMINED THAT 88.1% (171/194) ACHIEVED FINAL SUCCESSFUL REVASCULARIZATION (TICI=2B). MEDIAN TIME FROM ONSET OF SYMPTOMS TO GROIN PUNCTURE WAS 238 MINUTES. PROCEDURAL TIME (GUIDING CATHETER PLACEMENT TO REVASCULARIZATION TICI=2B OR END OF THE PROCEDURE) WAS 20 (MEAN, 29±27) MINUTES. THE MEAN NUMBER OF PASSES WITH THE DEVICE WAS 1.5. AT THE 90-DAY FOLLOW-UP VISIT, FAVORABLE NEUROLOGICAL OUTCOME (MRS, 0¿2) WAS SEEN IN 57.9% OF PATIENTS. MOST COMMON ANGIOGRAPHIC COMPLICATION IN CORE LABORATORY EVALUATION WAS VASOSPASM FOUND IN 23% (45/200) OF PATIENTS, ONLY 0.5% (1/202) WERE SYMPTOMATIC. THE FREQUENCY OF TOTAL DEVICE- AND PROCEDURE-RELATED SAES WAS (B)(4)%. ANY INTRACEREBRAL HEMORRHAGE (ICH) WAS FOUND IN 18.8% PATIENTS AT 24 HOURS AND SYMPTOMATIC ICH (SICH) OCCURRED IN 1.5% OF THE PATIENTS. THE MORTALITY RATE WAS (B)(4)% WITH A HIGHER PROPORTION FOUND IN THE MALE POPULATION (5%). THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: MORTALITY RATE WAS (B)(4)% (14 PATIENTS)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092145 SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death