BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 8228886 · Received January 8, 2019

    Report

    Report Number
    1226348-2019-00818
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    December 17, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THIS TIME. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿SPONTANEOUS DELAYED PROXIMAL MIGRATION OF ENTERPRISE STENT AFTER STAGED TREATMENT OF WIDE NECKED BASILAR ANEURYSM: TECHNICAL CASE REPORT ¿ A (B)(6) YEAR-OLD FEMALE PATIENT WITH A LARGE UNRUPTURED WIDE- NECKED BASILAR ANEURYSM AND SMALL UNRUPTURED RIGHT SUPERIOR CEREBELLAR AND LEFT ANTERIOR CEREBRAL ARTERY ANEURYSMS UNDERWENT A TWO-STAGE ENTERPRISE STENT ASSISTED COIL-EMBOLIZATION HAS EXPERIENCE STENT MIGRATION. THE STENT HAS MIGRATED PROXIMALLY WITH ALL 4 DISTAL TINES OF THE STENT WITHIN THE NECK OF THE ANEURYSM, AND THE PROXIMAL TINES NEARING THE VERTEBRAL BASILAR JUNCTION. THE DECISION WAS MADE TO PROCEED WITH COIL EMBOLIZATION AS THE STENT POSITION APPEARED TO BE IN THE ¿WAFFLE CONE¿ CONFIGURATION. THE ANEURYSM WAS THEN CATHETERIZED WITH A PROWLER-14 MICROCATHETER (CORDIS NEUROVASCULAR, INC.) OVER A SYNCHRO 2 SOFT GUIDEWIRE. AFTER THIS, CORDIS ORBIT COILS (CORDIS NEUROVASCULAR, INC.) WERE DEPLOYED INTO THE ANEURYSM. THE COIL LOOPS APPROACHED THE LEFT AND RIGHT PCA ORIGINS; HOWEVER, EXCELLENT FLOW REMAINED IN THESE VESSELS. THE ANEURYSM DEMONSTRATED NO EVIDENCE OF EXTRAVASATION, AND THERE WAS NO EVIDENCE OF DISTAL BRANCH OCCLUSION ON FOLLOW- UP ANGIOGRAPHIC IMAGES. HOWEVER, THERE WAS REMAINING FLOW IN THE ANEURYSM IN THE MOST DEPENDENT PORTION OF THE DOME REGION. NO ADDITIONAL COILS WERE PLACED BECAUSE OF THE THROMBOTIC EVENT. THE INTRAVENOUS REOPRO INFUSION WAS MAINTAINED OVERNIGHT. THE PATIENT WAS THEN AWAKENED FROM THE GENERAL ANESTHETIC AND HAD NO EVIDENCE OF IATROGENIC NEUROLOGICAL DEFICIT. AIM OF THIS STUDY: TO DEMONSTRATE A UNIQUE TECHNICAL ISSUE WITH A RELATIVELY NEWLY RELEASED INTRAVASCULAR STENT USED FOR ADJUNCTIVE TREATMENT OF WIDE- NECKED CEREBRAL ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22094 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR