BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR2

    MDR report key: 6906316 · Received September 29, 2017

    Report

    Report Number
    2029214-2017-01089
    Event Type
    Death
    Date Received
    September 29, 2017
    Date of Event
    September 1, 2017
    Report Date
    October 17, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K141491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIBOLD, F., MORDASINI, P., MOSIMANN, P., PIECHOWIAK, E., DOBROCKY, T., FISCHER, U., . . . GRALLA, J. (2017). SAFETY OF THE SOLITAIRE 4 × 40 MM STENT RETRIEVER IN THE TREATMENT OF ISCHEMIC STROKE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. DOI:10.1007/S00270-017-1785-Z. THE SOLITAIRE FR 2 DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2017-01088. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT OF PATIENT DEATHS AFTER SOLITAIRE 2 FR MECHANICAL THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE SOLITAIRE 2 FR 4X40 FOR LARGE VESSEL OCCLUSION IN STROKE PATIENTS. THE AUTHORS RETROSPECTIVELY REVIEWED 23 PATIENTS WITH OCCLUSIONS IN THE ANTERIOR OR POSTERIOR CEREBRAL CIRCULATION. THE ARTICLE DID NOT PROVIDE PATIENT DEMOGRAPHIC INFORMATION. THE ARTICLE STATES THAT TWO PATIENTS (PATIENTS 17 AND 21) WITH BASILAR OCCLUSION DIED THE DAY AFTER SUCCESSFUL THROMBECTOMY DUE TO MASSIVE INFARCTS IN THE VERTEBROBASILAR TERRITORY. IN ADDITION, AS OF 90 DAYS POST-PROCEDURE, FIVE ADDITIONAL PATIENTS HAD DIED DUE TO STROKE OR STROKE-RELATED COMPLICATIONS. PES RELATED TO THIS ARTICLE: (B)(4) ¿ ADVERSE EVENTS (B)(4) - DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685598 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR2-4-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Death