BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 10862271 · Received November 18, 2020

    Report

    Report Number
    2029214-2020-01140
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    May 25, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS REPRESENTATIVE OF THE MEAN PATIENT AGE OF THE PATIENT'S INCLUDED IN THE STUDY GROUP. PATIENT SEX OF MALE IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS IN THE STUDY GROUP (67.3%). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    YANG, B., WANG, T., CHEN, Y., WANG, Y., GAO, P., LI, G., CHEN, F., LI, L., WANG, Z., ZHANG, H., SONG, H., MA, Q., JIAO, L. (2020). IMPACT OF THE COVID-19 PANDEMIC ON THE PROCESS AND OUTCOME OF THROMBECTOMY FOR ACUTE ISCHEMIC STROKE. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 12(7), 664-668. DOI:10.1136/NEURINTSURG-2020-016177. ABSTRACT: BACKGROUND: THE NOVEL CORONAVIRUS DISEASE 2019 (COVID-19) PANDEMIC IS STILL SPREADING ACROSS THE WORLD. ALTHOUGH THE PANDEMIC HAS AN ALL-ROUND IMPACT ON MEDICAL WORK, THE DEGREE OF ITS IMPACT ON ENDOVASCULAR THROMBECTOMY (EVT) FOR PATIENTS WITH ACUTE ISCHEMIC STROKE (AIS) IS UNCLEAR. METHODS: WE CONTINUOUSLY INCLUDED AIS PATIENTS WITH LARGE ARTERY OCCLUSION WHO UNDERWENT EVT IN A COMPREHENSIVE STROKE CENTER BEFORE AND DURING THE WUHAN SHUTDOWN. THE PROTECTED CODE STROKE (PCS) FOR SCREENING AND TREATING AIS PATIENTS WAS ESTABLISHED DURING THE PANDEMIC. THE EFFICACY AND SAFETY OUTCOMES INCLUDING THE RATE OF SUCCESSFUL REPERFUSION (DEFINED AS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) GRADED 2B OR 3) AND TIME INTERVALS FOR REPERFUSION WERE COMPARED BETWEEN TWO GROUPS: PRE-PANDEMIC AND PANDEMIC. RESULTS: A TOTAL OF 55 AIS PATIENTS WHO RECEIVED EVT WERE INCLUDED. THE BASELINE CHARACTERISTICS WERE COMPARABLE BETWEEN THE TWO GROUPS. THE TIME FROM HOSPITAL ARRIVAL TO PUNCTURE (174 VS 125.5 MIN; P=0.002) AND TIME FROM HOSPITAL ARRIVAL TO REPERFUSION (213 VS 172 MIN; P=0.047) WERE SIGNIFICANTLY PROLONGED IN THE PANDEMIC GROUP COMPARED WITH THE PRE-PANDEMIC GROUP. THE RATE OF SUCCESSFUL REPERFUSION WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS (85.7% (N=18) VS 88.2% (N=30); OR 0.971, 95% CI 0.785 TO 1.203; P=1.000). CONCLUSION: THE RESULTS OF THIS STUDY SUGGEST A PROPER PCS ALGORITHM WHICH COMBINES THE COVID-19 SCREENING AND PROTECTION MEASURES COULD DECREASE THE IMPACT OF THE DISEASE ON THE CLINICAL OUTCOMES OF EVT FOR AIS PATIENTS TO THE LOWEST EXTENT POSSIBLE DURING THE PANDEMIC. THE FINAL STUDY GROUP INCLUDED 55 PATIENTS WHO SUFFERED ACUTE ISCHEMIC STROKE (AIS) CAUSED BY INTRACRANIAL LARGE ARTERY OCCLUSION, 34 PATIENTS WERE FROM THE PRE-PANDEMIC GROUP, AND 21 WERE FROM THE PANDEMIC GROUP. OF THE 55 PATIENTS IN THE STUDY GROUP, 37 OF THE PATIENTS WERE MALE (67.3%). THE MEAN AGE WAS 65.1 YEARS +/- 13.1 YEARS. IN THE PRE-PANDEMIC GROUP OF INCLUDED PATIENTS, THE MEDIAN PREOPERATIVE NIHSS SCORE WAS 13; SCORES RANGED 11-17. IN THE PANDEMIC GROUP OF INCLUDED PATIENT, THE MEDIAN NIHSS SCORE WAS 12; SCORES RANGED 11-18. THERE WERE MULTIPLE TYPES OF PROCEDURES AND DEVICES USED FOR THE VARYING THROMBECTOMY PROCEDURES IN THE STUDY. THE MEDTRONIC SOLITAIRE THROMBUS RETRIEVAL DEVICE WAS MENTIONED IN THE ARTICLE AS ONE SUCH DEVICE BUT WAS ALSO NOTED TO NOT BE THE DEVICE USED IN THE MAJORITY OF CASES. HOWEVER, IN THE STUDY OUTCOMES, THE RESULTS DO NOT DIFFERENTIATE REGARDING WHICH OUTCOMES RELATE TO WHAT DEVICE(S) WERE USED IN THE PROCEDURE, THUS THE OUTCOMES AND EVENT WERE PROCESSED WITH THE CONSIDERATION THAT A SOLITAIRE MAY HAVE BEEN USED. RESCUE TREATMENT WAS REQUIRED IN 10% OF THE CASES IN THE PRE-PANDEMIC GROUP AND IN 5% OF CASES IN THE PANDEMIC GROUP. THE PRIMARY OUTCOME NOTED IN THE STUDY WAS SUCCESSFUL REPERFUSION. PLI10: POSSIBLE SERIOUS INJURIES NOTED POST-OPERATIVELY REPORTEDLY INVOLVED 18 PATIENTS. A TOTAL OF 12 PATIENTS FROM BOTH PRE-PANDEMIC AND PANDEMIC GROUPS EXPERIENCED INTRACRANIAL HEMORRHAGE, 7 EXPERIENCED SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325370 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE NOT-RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other