BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURFORM3 MICRODELIVERY STENT SYSTEM

    MDR report key: 951498 · Received November 19, 2007

    Report

    Report Number
    6000078-2007-00313
    Event Type
    Injury
    Date Received
    November 19, 2007
    Date of Event
    September 3, 2007
    Report Date
    October 23, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTED PT COMPLICATIONS AND PT CONDITION IS GOOD. HOWEVER, STENT IMPLANTED IN UNINTENDED SITE. ADDITIONAL: PMA/501(K)#: H020002/S5. PER ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY CONTACT. "...PHYSICIAN SAID THE SECOND ONE WAS DUE TO HIS MISTAKE." THE ADDITIONAL INFORMATION HAS AIDED BOSTON SCIENTIFIC TO DETERMINE THE MOST PROBABLE CAUSE OF THE USER'S EXPERIENCE TO BE USE RELATED (USER INTERFACE CONTRIBUTED TO EVENT).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER A STENTING PROCEDURE OF THE ICA (INTERNAL CAROTID ARTERY) WAS ATTEMPTED. WHILE ADVANCING THE FIRST STENT (SEE MFG REPORT #6000078-2007-00233) "...PREMATURELY DEPLOYED IN THE ICA [INTERNAL CAROTID ARTERY] BEFORE REACHING THE TARGET LESION OF DISTAL ICA, SO ANOTHER STENT WAS TRIED..." WHILE ATTEMPTING, THE GUIDING CATHETER GOT TRAPPED IN THE FIRST STENT, "..AND THE SECOND STENT PREDEPLOYED..." (SUSPECT DEVICE). THE SECOND STENT OVERLAPPED THE FIRST STENT A LITTLE BIT. THE PROCEDURE WAS NOT COMPLETED DUE TO THESE ISSUES. THERE WERE NO PT COMPLICATIONS AND THE PT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURFORM3 MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other GUIDER CATHETER| NEUROFORM STENT (6000078-2007-00233)| THERAPY DATE| TRANSEND GUIDEWIRE