BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE

    MDR report key: 6028598 · Received October 13, 2016

    Report

    Report Number
    2029214-2016-00901
    Event Type
    Death
    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

    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

    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 RESTROSPECTIVE 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 THE INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MDR 2029214-2016-00900 FOR THE OTHER MDR FROM THIS ARTICLE. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH A LITERATURE REVIEW THAT MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE REVIEW THAT THE PATIENT DID NOT IMPROVE AFTER TREATMENT WITH THE SOLITAIRE DEVICE. THIS PATIENT WAS AN (B)(6) FEMALE WITH A HISTORY OF A PREVIOUS STROKE (CVA). THE LOCATION OF THE THROMBUS WAS LOCATED IN THE BASILAR TERMINUS AND THE ETIOLOGY OF THE STROKE WAS CARDIOEMBOLIC. THE PATIENT RECEIVED IV-TPA AND UNDERWENT MECHANICAL THROMBECTOMY AND ANGIOPLASTY. APPROX 3 PASSES WERE MADE WITH THE SOLITAIRE DEVICE RESULTING IN TICI 1. ANGIOPLASTY WAS THEN PERFORMED WHEN THE MECHANICAL THROMBECTOMY WAS UNSUCCESSFUL. REVASCULARIZATION COULD NOT BE ACHIEVED AND THE PATIENT DIED AS AN INPATIENT. BASELINE NIHSS WAS 28 AND THE POST PROCEDURE MRS WAS 6 (DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679965 SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death