BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 16054060 · Received December 27, 2022

    Report

    Report Number
    2029214-2022-02189
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    September 8, 2021
    Report Date
    May 10, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANNEX A CODE CORRECTED IN H6 SECTION. 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.

    Additional Manufacturer Narrative · 0

    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

    BUTT, W., KIM C., RAMASWAMY, R., SMITH, A., MALLAKA, P. IMPLANTATION OF LARGE DIAMETER (5.5¿6MM) DERIVO EMBOLIZATION DEVICES FOR THE TREATMENT OF CEREBRAL ANEURYSMS. CLIN NEURORADIOL (2022) 32:481¿489. DOI: HTTPS://DOI.ORG/10.1007/S00062-021-01086-2 SUMMARY: THE EFFICACY OF FLOW DIVERTERS IS DEPENDENT UPON ROBUST WALL APPOSITION IN THE PARENT ARTERY. USAGE IN LARGE CALIBER CEREBRAL VESSELS HAS THEREFORE BEEN LIMITED AS FEW IMPLANTS WITH DIAMETERS >5MM EXIST. WE PRESENT OUR INITIAL EXPERIENCE IN TREATING CEREBRAL ANEURYSMS USING THE 5.5MM AND 6MM DIAMETER IMPLANTS OF THE DERIVO EMBOLIZATION DEVICE (DED). OUR PROSPECTIVELY MAINTAINED INSTITUTIONAL DATABASE WAS REVIEWED TO IDENTIFY PATIENTS IN WHOM A>5MM DED WAS IMPLANTED BETWEEN NOVEMBER 2016 AND FEBRUARY 2021. THE PRIMARY EFFICACY OUTCOME WAS COMPLETE OR NEAR-COMPLETE ANEURYSM OCCLUSION AT 6 MONTHS (O¿KELLY-MAROTTA, OKM, C¿D, ADAPTED FOR MAGNETIC RESONANCE ANGIOGRAPHY). SAFETY OUTCOMES INCLUDED 30-DAY MAJOR MORBIDITY DEFINED AS MODIFIED RANKIN SCORE (MRS) 3¿5, MORTALITY, SERIOUS ADVERSE EVENTS AND PROCEDURAL COMPLICATIONS. A TOTAL OF 21 LARGE DIAMETER DEDS WERE DEPLOYED IN 18 PATIENTS (AGE 59.5± 14.1 YEARS), HARBORING 19 UNRUPTURED ANEURYSMS. OF THE ANEURYSMS 14 (73.7%) WERE SACCULAR IN MORPHOLOGY (SAC DIAMETER 10.9± 5.5MM, NECK DIAMETER 6.8± 3.1MM), 3 (15.8%) ANEURYSMS WERE DISSECTING, 1 (5.3%) IATROGENIC PSEUDOANEURYSMAND 1 (5.3%) FUSIFORM. ANEURYSM LOCATIONS WERE: ICA (INTERNAL CAROTID ARTERY) (N= 17); (7 CAVERNOUS, 4 PARAOPHTHALMIC, 2 PARACLINOID, 1 PETROUS, 2 COMMUNICATING, 1 CERVICAL); VERTEBROBASILAR (N= 2). ADJUNCT STENTING TO OPTIMIZE PROXIMAL WALL APPOSITION WAS UNDERTAKEN IN 5 (27.8%) PATIENTS. AT 6 MONTHS 75% OF PATIENTS FOLLOWED-UP MET THE PRIMARY EFFICACY ENDPOINT (OKM C¿D). THERE WERE NO SERIOUS ADVERSE EVENTS, 30-DAY MAJOR MORBIDITY (MRS 3¿5) OR MORTALITY. CONCLUSION IMPLANTATION OF LARGE DIAMETER (5.5MM AND 6MM) DEDS INTO CAPACIOUS CEREBRAL VESSELS TO TREAT A RANGE OF COMPLEX ANEURYSMS IS SAFE AND TECHNICALLY FEASIBLE BUT MAY REQUIRE ADJUNCT STENTING TO OPTIMIZE PROXIMAL WALL APPOSITION. SHORT-TERM EFFICACY OF THIS DEVICE SUBSET IS COMPARABLE TO PREVIOUS DED AND OTHER FLOW DIVERTER STUDIES. LONG-TERM FOLLOW-UP AND COMPARATIVE STUDIES ARE REQUIRED FOR FURTHER ASSESSMENT. REPORTED EVENTS: 1. THERE WAS ONE PSEUDOANEURYSM AT THE FEMORAL ARTERIAL ACCESS SITE WHICH WAS REPAIRED SURGICALLY. NO OTHER SERIOUS ADVERSE EVENTS, INCLUDING NEW NEUROLOGICAL DEFICITS AND STROKE, WERE IDENTIFIED IN THE PATIENT RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2652680 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention