BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7978792 · Received October 18, 2018

    Report

    Report Number
    1226348-2018-00740
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    December 31, 2012
    Report Date
    September 24, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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" NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿THE PENUMBRA COIL 400 SYSTEM FOR TREATMENT OF WIDE-NECKED INTRACRANIAL ANEURYSMS: INITIAL SINGLE-CENTER EXPERIENCE¿: A PATIENT FROM A GROUP ¿PENUMBRA COIL 400 SYSTEM¿ WITH WIDE-NECKED INTRACRANIAL ANEURYSM UNDERWENT THE ENTERPRISE STENT-ASSISTED COIL (SAC) EMBOLIZATION, SUFFERED A SIGNIFICANT RECURRENCE (RECANALIZATION) WITH RECOMMENDED RETREATMENT. TITLE: ¿THE PENUMBRA COIL 400 SYSTEM FOR TREATMENT OF WIDE-NECKED INTRACRANIAL ANEURYSMS: INITIAL SINGLE-CENTER EXPERIENCE.¿ THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE FREQUENCY OF ADJUNCTIVE STENT USAGE WHEN COILING WIDE-NECKED INTRACRANIAL ANEURYSMS WITH THE PC-400 IN COMPARISON WITH CONVENTIONAL COILS. METHOD: BETWEEN OCTOBER 2008 AND DECEMBER 2012. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE CHOICE OF ENDOVASCULAR COILS: PC-400 AND CONVENTIONAL COILS (CASHMERE, MICRUSPHERE, DELTAWIND, AND ULTIPAQ: CODMAN & SHURTLEFF, INC., RAYNHAM MA, USA; HYDROGEL, COSMOS, COMPLEX, AND HYPERSOFT: MICROVENTION, INC., TUSTIN CA, USA). ALL PATIENTS HAD PLANNED ADJUNCTIVE STENTING WITH EITHER AN ENTERPRISE (CODMAN & SHURTLEFF, INC., RAYNHAM MA, USA) OR NEUROFORM (STRYKER CORPORATION, KALAMAZOO MI, USA) INTRACRANIAL STENT. ONLY UNRUPTURED ANEURYSMS WERE CONSIDERED IN THE PRESENT ANALYSIS BECAUSE ADJUNCTIVE STENT PLACEMENT IS A RARITY AFTER ANEURYSM SUBARACHNOID HEMORRHAGE WHERE ANTIPLATELET THERAPY IS A RELATIVE CONTRAINDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817870 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention