BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 11379017 · Received February 25, 2021

    Report

    Report Number
    2029214-2021-00205
    Event Type
    Death
    Date Received
    February 25, 2021
    Date of Event
    November 13, 2018
    Report Date
    February 25, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    GIANNI BORIS BRADAC, FABRIZIO VENTURI, GIOVANNI BOSCO, DOMENICA GARABELLO, MARIO CORIASCO, GUIDO STURA, GIANCARLO VENTILII, MAURO BE RGUI, PAOLO CERRATO. ACUTE OCCLUSION OF THE DISTAL INTERNAL CAROTID ARTERY. CLINICAL NEURORADIOLOGY 30 (2020). DOI: 10.1007/S00062-018-0743-8 ABSTRACT PURPOSE THE ACUTE DISTAL INTRACRANIAL OCCLUSION OF THE INTERNAL CAROTID ARTERY (ICA) IS A VERY COMPLEX HETEROGENEOUS PATHOLOGY, CHARACTERIZED BY VARIOUS PATTERNS. AIM OF THIS WORK IS TO IDENTIFY THE DIFFERENT TYPES AND PROPOSE A CLASSIFICATION. METHODS AMONG THE PATIENTS ADMITTED FOR STROKE IN THE ANTERIOR CIRCULATION FROM AUGUST 2014 TO OCTOBER 2017, 46 (25%) PRESENTED WITH INTRACRANIAL DISTAL CAROTID ARTERY OCCLUSION. THE MEAN AGE OF THE PATIENTS WAS 71 (SD 13.7), 65,2% FEMALE. THE PROTOCOL INCLUDED GENERAL AND SPECIFIC NEUROLOGICAL EXAMINATIONS, CT, CT-ANGIOGRAPHY WITH MULTIPHASE CTA, FOLLOWED BY ANGIOGRAPHY. THE OCCLUSION WAS TREATED BY ASPIRATION DEVICE ALONE OR ASSOCIATED WITH STENT-RETRIEVER. NIHSS AT THE ADMISSION, AT DISCHARGE AND MODIFIED RANKING SCALE (MRS) AT FOUR MONTHS WERE EXAMINED. RESULTS THE OCCLUSIONS PRESENTED WITH VARIOUS PATTERNS. DEPENDING ON ITS SITE (LOCATED AT THE DISTAL ICA BIFURCATION OR MORE PROXIMAL AT THE LEVEL OF THE OPHTHALMIC SEGMENT OF ICA, WITH OR WITHOUT EXTENT TO ICA BIFURCATION) TAKING ALSO INTO ACCOUNT THE VARIOUS INVOLVEMENT OF THE CEREBRAL VESSELS AND ANATOMIC VARIATIONS OF CIRCLE OF WILLIS, THREE GROUPS OF OCCLUSION TYPES COULD BE IDENTIFIED (T1, T2 AND T3). THE COLLATERAL CIRCULATION, AND THE POSSIBILITIES OF THE ENDOVASCULAR REVASCULARIZATION IMPORTANT FOR THE FINAL OUTCOME, WERE CLEARLY CONNECTED WITH THE TYPE OF OCCLUSION. NIHSS AT ADMISSION WAS 19.1 (RANGE FROM 8 TO 30, SD 4.4). GOOD OUTCOME DEFINED AS MRS 0-2 AT FOR MONTHS WAS OBTAINED IN 17 PATIENTS (37%). CONCLUSIONS THE PROPOSED CLASSIFICATION REPRODUCES MORE PRECISELY THE COMPLEXITY AND HETEROGENEITY OF THIS PATHOLOGY, BEING USEFUL IN THE DIAGNOSIS AND TREATMENT OF THESE PATIENTS. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T3A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD MALE UNDERWENT TREATMENT FOR A T2A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS; HOWEVER, THE TREATMENT WAS LISTED AS A FAILURE (NO REVASCULARIZATION). THE OUTCOME OF THE PATIENT WAS THAT THEY DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE COMPLETE REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD MALE UNDERWENT TREATMENT FOR A T2A. PATIENT COMPLICATIONS INCLUDED HEMORRHAGE. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE COMPLETE REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD MALE UNDERWENT TREATMENT FOR A T2A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE COMPLETE REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2A. PATIENT COMPLICATIONS INCLUDED DISTAL EMBOLIZATION. THE RESULTS OF THE TREATMENT WERE COMPLETE REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2A. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS; HOWEVER, THE TREATMENT WAS LISTED AS A FAILURE (NO REVASCULARIZATION). THE OUTCOME OF THE PATIENT WAS THAT THEY DIED. - A (B)(6) YEAR OLD MALE UNDERWENT TREATMENT FOR A T2B, P. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS; HOWEVER, THE TREATMENT WAS LISTED AS A FAILURE (NO REVASCULARIZATION). THE OUTCOME OF THE PATIENT WAS THAT THEY DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2B, P. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS; HOWEVER, THE TREATMENT WAS LISTED AS A FAILURE (NO REVASCULARIZATION). THE OUTCOME OF THE PATIENT WAS THAT THEY DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2B. PATIENT COMPLICATIONS INCLUDED DISTAL EMBOLIZATION. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2B. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2B. PATIENT COMPLICATIONS INCLUDED HEMORRHAGE. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED. - A (B)(6) YEAR OLD FEMALE UNDERWENT TREATMENT FOR A T2B. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE RESULTS OF THE TREATMENT WERE PARTIAL REVASCULARIZATION; HOWEVER, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275894 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death