BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKENTERPRISE2

    MDR report key: 12563124 · Received October 1, 2021

    Report

    Report Number
    1226348-2021-00064
    Event Type
    Death
    Date Received
    October 1, 2021
    Date of Event
    January 5, 2016
    Report Date
    October 1, 2021
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). LITERATURE ARTICLE EMERGENT REVASCULARIZATION OF ACUTE TANDEM VERTEBROBASILAR OCCLUSIONS: ENDOVASCULAR APPROACHES AND TECHNICAL CONSIDERATIONS-CONFIRMING THE ROLE OF VERTEBRAL ARTERY OSTIUM STENOSIS AS A CAUSE OF VERTEBROBASILAR STROKE REVIEWED. COHEN JE, LEKER RR, GOMORI JM, EICHEL R, RAJZ G, MOSCOVICI S, ITSHAYEK E. J CLIN NEUROSCI. 2016 DEC;34:70-76. DOI: 10.1016/J.JOCN.2016.05.005. EPUB 2016 AUG 10. PMID: 27522497. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2021-00482. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE EMERGENT REVASCULARIZATION OF ACUTE TANDEM VERTEBROBASILAR OCCLUSIONS: ENDOVASCULAR APPROACHES AND TECHNICAL CONSIDERATIONS-CONFIRMING THE ROLE OF VERTEBRAL ARTERY OSTIUM STENOSIS AS A CAUSE OF VERTEBROBASILAR STROKE REVIEWED. COHEN JE, LEKER RR, GOMORI JM, EICHEL R, RAJZ G, MOSCOVICI S, ITSHAYEK E. J CLIN NEUROSCI. 2016 DEC;34:70-76. DOI: 10.1016/J.JOCN.2016.05.005. EPUB 2016 AUG 10. PMID: 27522497. OBJECTIVE AND METHODS: PATIENTS SUFFERING FROM ACUTE ATHEROTHROMBOTIC OCCLUSION OF THE PROXIMAL VERTEBRAL ARTERY (VA) AND CONCOMITANT BASILAR ARTERY (BA) OCCLUSION PRESENT A GRIM PROGNOSIS. WE DESCRIBE OUR EXPERIENCE IN THE ENDOVASCULAR RECANALIZATION OF TANDEM VERTEBROBASILAR OCCLUSIONS USING ENDOVASCULAR TECHNIQUES. THE BA WAS ACCESSED THROUGH THE NORMAL VA (CLEAN-ROAD) OR THE OCCLUDED, THROMBOTIC VA (DIRTY-ROAD), AND STENTRIEVER-BASED THROMBECTOMY WAS PERFORMED USING ANTEGRADE OR REVERSE REVASCULARIZATION VARIANTS. SEVEN PATIENTS UNDERWENT SUCCESSFUL STENTRIEVER-ASSISTED MECHANICAL THROMBECTOMY OF THE BA AND FIVE SUSTAINED CONCOMITANT VA REVASCULARIZATION. STROKE ONSET TO ENDOVASCULAR INTERVENTION INITIATION (TIME-TO-TREATMENT) RANGED FROM 4.5¿13 HOURS (MEAN 8.6). IN TWO OF SEVEN PATIENTS, THE BA OCCLUSION WAS APPROACHED WITH A ¿CLEAN-ROAD¿ APPROACH VIA THE CONTRALATERAL VA; IN FIVE OF SEVEN PATIENTS, A ¿DIRTY-ROAD¿ APPROACH VIA THE OCCLUDED VA WAS USED. . MEAN TIME-TO-RECANALIZATION WAS 66 MINUTES (RANGE 55¿82). THERE WERE NO PERFORATIONS, IATROGENIC VESSEL DISSECTIONS, OR OTHER TECHNICAL COMPLICATIONS. FOUR PATIENTS PRESENTED MILD-TO-MODERATE DISABILITY (MODIFIED RANKIN SCALE [MRS] 0¿3) AT 3 MONTHS, ONE REMAINED WITH MODERATE-TO-SEVERE DISABILITY (MRS 4), AND TWO PATIENTS DIED ON DAYS 9 AND 23 AFTER THEIR STROKES. FOLLOW-UP RANGED FROM 6¿45 MONTHS (MEAN 24 MONTHS). IN SELECTED PATIENTS WITH ACUTE VA-BA OCCLUSION, STENTRIEVER-BASED THROMBECTOMY PERFORMED THROUGH EITHER THE PATENT OR THE OCCLUDED VA, MAY BE FEASIBLE, EFFECTIVE, AND SAFE. CLINICAL OUTCOMES IN THESE PATIENTS SEEM TO EQUIPOISE THE NEUROLOGICAL OUTCOME OF PATIENTS WITH SUCCESSFUL REVASCULARIZATION FOR ISOLATED BA OCCLUSION. THIS UNIQUE PAIR OF OCCLUSIONS CONFIRMS THE ROLE OF VA OSTIUM STENOSIS AS A CAUSE OF VERTEBROBASILAR STROKE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENVOY CATHETER AND ENTERPRISE NEUROSTENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: REBAR, EV3, PLYMOUTH, MN, USA; EXCEL, STRYKER, KALAMAZOO, MI, USA; MICROGUIDEWIRE, BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS:" PATIENT NUMBER 3 DIED FROM SEPTIC SHOCK 23 DAYS AFTER THE PROCEDURE. AN ENVOY CATHETER AND ENTERPRISE NEUROSTENT WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459266 UNKENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXCEL, STRYKER| MICROGUIDEWIRE, BOSTON SCIENTIFIC| REBAR, EV3, PLYMOUTH