BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 889832 · Received September 28, 2006

    Report

    Report Number
    6000078-2006-00469
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Date of Event
    September 14, 2006
    Report Date
    September 14, 2006
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    MAF
    PMA / PMN Number
    H020002/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K): H020002/S5. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT WAS DISCARDED BY THE HOSP. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. BOSTON SCIENTIFIC WILL REVIEW THE DEVICE HISTORY RECORD (DHR) OF THE DEVICE IN QUESTION, AND A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DURING A STENT SUPPORTED ANEURYSM COILING, THE SECOND STENT "JUMPED FORWARD AND PARTIALLY DEPLOYED". THE PHYSICIAN REPORTED THAT WHEN HE TRIED TO REMOVE THE SECOND STENT, IT CAUGHT ON A PREVIOUSLY DEPLOYED STENT AND DAMAGED IT. THE SECOND STENT WAS REMOVED AND DISCARDED. THE FIRST STENT REMAINED INSIDE THE PT, AND THE PROCEDURE WAS POSTPONED UNTIL THE FOLLOWING DAY. NO FURTHER DETAILS REGARDING THE EVENT DESCRIPTION WERE DISCLOSED. THE PT IS REPORTEDLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM INTRAVASCULAR STENT MAF NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP SNF345200 8558966

    Patients

    Seq Age Sex Outcome Treatment
    1 *