BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE

    MDR report key: 6028563 · Received October 13, 2016

    Report

    Report Number
    2029214-2016-00900
    Event Type
    Injury
    Date Received
    October 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR 2029214-2016-00901 FOR THE OTHER MDR FROM THIS ARTICLE.

    Additional Manufacturer Narrative · 1

    CITATION: ASHISH SONIG, MD, MS, MCH, CHANDAN KRISHNA, MD, SABAREESH K. NATARAJAN, MD, MS, JIAN LIU, MD, L. NELSON HOPKINS, MD, KENNETH V. SNYDER, MD, PHD, ELAD I. LEVY, MD, MBA, ADNAN H. SIDDIQUI, MD, PHD. STENT RETRIEVER-ASSISTED MECHANICAL THROMBECTOMY FOR ACUTE BASILAR ARTERY OCCLUSION: SINGLE US INSTITUTION EXPERIENCE. OPERATIVE NEUROSURGERY 12:250¿259, 2016 WWW.OPERATIVENEUROSURGERY-ONLINE.COM THIS ARTICLE WAS A RETROSPECTIVE REVIEW OF ALL PATIENTS TREATED WITH STENT RETRIEVERS FOR POSTERIOR STROKE BETWEEN JUNE 2012 AND JUNE 2014 AT GATES VASCULAR INSTITUTE-KALEIDA HEALTH. IN THE PRESENT STUDY, NO DEVICE-RELATED COMPLICATIONS OCCURRED AND NONE OF THE PATIENT¿S HAD HEMORRHAGIC TRANSFORMATION OF STROKE OR ANY OTHER PARENCHYMAL BLEED. THE APPLICATION OF THE STENT RETRIEVERS HAS DECREASED RECANALIZATION TIME. THE AUTHOR CONCLUDED THAT BY REDUCING PROCEDURE TIME AND AVOIDING THROMBOEMBOLIC COMPLICATIONS, GOOD CLINICAL OUTCOMES AND GOOD RECANALIZATION WITH ACCEPTABLE MORTALITY CAN BE ACHIEVED WITH CURRENT STENT RETRIEVERS (SOLITAIRE). THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 INFORMATION THROUGH A LITERATURE REVIEW THAT THE PATIENT DID NOT IMPROVE AFTER TREATMENT WITH THE SOLITAIRE DEVICE. THE PATIENT WAS A (B)(6) YEAR OLD MALE WITH UNKNOWN STROKE ETIOLOGY. THE PATIENT HAD PRESENTED WITH RIGHT-SIDED HEMIPARESIS, DYSARTHRIA, AND THROMBUS IN THE PROXIMAL BASILAR (PB). A CT STROKE STUDY SHOWED COMPLETE OCCLUSION OF THE BASILAR ARTERY (BA). IV-TPA WAS NOT ADMINISTERED AND TIME TO REVASCULARIZATION WAS 43 MINUTES. TICI PRE-THROMBECTOMY WAS 0. MECHANICAL THROMBECTOMY WITH THE SOLITAIRE AND TICI 3 FLOW WAS ACHIEVED IN 1 PASS. HOWEVER, THE PATIENT HAD NEW SYMPTOMS OF DYSPHAGIA ALONG WITH ASPIRATION PNEUMONIA AFTER THROMBECTOMY. POST PROCEDURE IMAGING SHOWED ACUTE AREAS OF INFARCTION IN THE BRAINSTEM INVOLVING THE LEFT MEDULLA AND LEFT PONS WITH A THIRD PUNCTATE FOCUS ANTEROLATERALLY IN THE RIGHT CEREBELLAR HEMISPHERE. A MICROEMBOLI SHOWER DURING CLOT RETRIEVAL WAS PRESUMED TO BE THE CAUSE. THE PATIENT HAD AN MRS SCORE OF 4 AT DISCHARGE AND AT THE LAST FOLLOW UP (98 DAYS). BASELINE NIHSS WAS 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678142 SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other