BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 17761638 · Received September 15, 2023

    Report

    Report Number
    2029214-2023-01736
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    October 17, 2022
    Report Date
    September 15, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT RELATED TO REGULATORY REPORT: 2029214-2023-01735. SEE ATTACHMENTS FOR LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    SHIMIN LIU, WENFENG CAO, LINGFENG WU, AN WEN, YONGLIANG ZHOU, ZHENGBING XIANG, WEI RAO, DONGYUAN YAO; JOURNAL OF NEURORADIOLOGY; 2023; 65:793¿804; ENDOVASCULAR TREATMENT OVER 24 HOURS AFTER ISCHEMIC STROKE ONSET: A SINGLE-CENTER RETROSPECTIVE STUDY; DOI.ORG/10.1 007/S00234-022-03105-6 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS TREATED WITH SOLITAIRE STENTS HAD COMPLICATIONS. THE AIM OF THIS STUDY IS TO EVALUATE THE SAFETY AND EFECTIVENESS OF ENDOVASCULAR TREATMENT (EVT) FOR ACUTE ISCHEMIC STROKE CAUSED BY LARGE-VESSEL OBSTRUCTION OR STENOSIS (AIS-LVO/S) OVER 24 HOURS AFTER FIRST AIS SYMPTOM RECOGNITION (FAISSR). A TOTAL OF 304 PATIENTS WITH AIS-LVO/S WERE TREATED WITH EVT DURING THE PERIOD FROM JANUARY 2019 TO FEBRUARY 2022 AT THE HOSPITAL INCLUDED IN STUDY, AND AMONG THEM, 271 AND 33 PATIENTS WERE TREATED WITH EVT WITHIN AND OVER 24 HOURS  FROM FIRST AIS SYMPTOM RECOGNITION (FAISSR), RESPECTIVELY. AMONG THE 33 PATIENTS [27 MALES AND 6 FEMALES, AGES: 62.9 YEARS], 17 WERE TRANSFERRED FROM OTHER HOSPITALS, 13 AGGRAVATED DURING HOSPITALIZATION, AND 3 REFUSED EVT AT THE BEGINNING OF HOSPITALIZATION. PROCEDURE: UNDER GENERAL ANESTHESIA AND LOCAL INFLTRATION WITH 2% LIDOCAINE, THE RIGHT FEMORAL ARTERY WAS PUNCTURED AND AN 8F CATHETER SHEATH WAS PLACED. THEN, CEREBRAL ANGIOGRAPHY WAS PERFORMED TO FURTHER DETERMINE THE INFARCTED BLOOD VESSELS. THE TECHNIQUES OF EVT INVOLVED DIRECT ASPIRATION, STENT THROMBECTOMY, BALLOON DILATION, AND STENT PLACEMENT. DIRECT ASPIRATION CONSISTED OF NAVIGATING A LARGE-BORE CATHETER UP TO THE FACE OF THE CLOT AND INITIATING FORCEFUL SUCTION. STENT THROMBECTOMY INCLUDED POSITIONING A MICROCATHETER BEYOND THE OCCLUDED SEGMENT OF ARTERY AND DEPLOYING A STENT RETRIEVER (SOLITAIRE) TO CATCH THE THROMBUS, AND PULLING OUT THE STENT FROM THE ARTERY UNDER CONTINUOUS ASPIRATION IN THE LARGER CATHETERS. BALLOON ANGIOPLASTY INVOLVED DILATING THE OBSTRUCTION OR STENOSIS AND OBSERVING FOR 15¿30 MIN AFTER DEFATION OF THE BALLOON TO DETERMINE WHETHER RE-ESTABLISHMENT OF BLOOD FOW AND MTICI>2B WERE ACHIEVED AND MAINTAINED. IF NOT, A SELF-EXPANDING NITINOL STENT WAS DEPLOYED.  RESULTS: THE REPERFUSION WAS SUCCESSFULLY ESTABLISHED IN 97% (32/33) OF PATIENTS, AND MOST PATIENTS (63.6%, 21/33) WITH EVT HAD 90D MRS = 2 WITH FAVORABLE OUTCOMES AND ONLY 36.4% (12/33) HAD 90D MRS > 2 WITH UNFAVORABLE OUTCOMES. INTRACRANIAL HEMORRHAGE (ICH) OCCURRED IN 21.2% (7/33) OF THE PATIENTS AND SYMPTOMATIC ICH (SICH) IN 3% (1/33), AND 18.2% (6/33) OF PATIENTS DIED WITHIN 90 DAYS AFTER EVT (INCLUDING ONE DIED OF PULMONARY INFECTION 2 MONTHS AFTER EVT).  THERE WAS NO SIGNIFICANT DIFFERENCE IN PERCENTAGE OF ACUTE ISCHEMIC STROKE (AIS) CAUSED BY ICA OR MCA STENOSIS OR OCCLUSION BETWEEN THE TWO GROUPS, WHILE THERE WAS SIGNIFICANTLY HIGHER PERCENTAGE OF THE AIS PATIENTS CAUSED BY VERTEBROBASILAR ARTERY (VBA) STENOSIS OR OCCLUSION IN THE UNFAVORABLE OUTCOME (UFO) GROUP IN COMPARISON WITH THOSE IN THE FAVORABLE OUTCOME (FO) GROUP. THE MORTALITY RATE WAS SIGNIFICANTLY HIGHER THAN THOSE IN THE PATIENTS WITH ANTERIOR CEREBRAL CIRCULATION STENOSIS OR OCCLUSION. IN FACT, ALL THE 6 AIS PATIENTS DIED IN THE STUDY WERE DUE TO POSTERIOR CEREBRAL CIRCULATION STENOSIS OR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269019 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H