BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC AVE S670D OTW CORONARY STENT SYSTEM

    MDR report key: 317472 · Received February 22, 2001

    Report

    Report Number
    2953200-2001-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2001
    Date of Event
    January 24, 2001
    Report Date
    January 24, 2001
    Manufacturer
    MEDTRONIC AVE, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5MM DIAMETER BY 15MM LENGTH S670 STENT DELIVERY SYSTEM WAS INSERTED FOR TREATMENT OF A LESION IN AN UNKNOWN CORONARY ARTERY. THE STENT DELIVERY SYSTEM WAS INSERTED OVERLAPPING A PREVIOUSLY DEPLOYED STENT THAT WAS SMALLER IN SIZE. DURING THE INFLATION OF THE STENT DELIVERY BALLOON TO 14ATM OF PRESSURE, THE BALLOON REPORTEDLY BURST. THE STENT DELIVERY BALLOON EXTENDED WITHIN THE PREVIOUSLY DEPLOYED STENT DURING THE INFLATION. THE STENT WAS SUCCESSFULLY DEPLOYED AND THERE WAS NO REPORT OF INJURY TO THE PT. THE BALLOON BURST LIKELY OCCURRED FROM BEING INFLATED WITHIN THE PREVIOUSLY DEPLOYED STENT, WHICH WAS SMALLER IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6945 MEDTRONIC AVE S670D OTW CORONARY STENT SYSTEM OVER-THE-WIRE CORONARY STENT SYSTEM MAF MEDTRONIC AVE, INC. NA 0J18E08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GUIDE CATHETER, GUIDEWIRE.