BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 2D 8MM X 30CM

    MDR report key: 3810248 · Received May 14, 2014

    Report

    Report Number
    3008853977-2014-00156
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 20, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SUBJECT DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT THE COIL WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT PROCEDURAL FACTORS LIMITED THE PERFORMANCE OF THE DEVICE DURING THE PROCEDURE RESULTING IN THE REPORTED ISSUE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE COIL PREMATURELY DETACHED RESULTING IN ABOUT 1CM OF THE COIL TO PROTRUDE INTO THE PARENT VESSEL. THE PHYSICIAN DEPLOYED A STENT TO SECURE THE COIL PORTION AGAINST THE VESSEL WALL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE COIL PREMATURELY DETACHED RESULTING IN ABOUT 1CM OF THE COIL TO PROTRUDE INTO THE PARENT VESSEL. THE PHYSICIAN DEPLOYED A STENT TO SECURE THE COIL PORTION AGAINST THE VESSEL WALL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288482 GDC-10 2D 8MM X 30CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15910083

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention