BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2192133 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03506
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN ION MONORAIL (MR) STENT DELIVERY SYSTEM (SDS) WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE STENT HAD MOVED DISTALLY 2 MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. BLUE FIBROUS FOREIGN MATTER WAS INTERTWINED IN THE FIRST THREE PROXIMAL ROWS OF THE STENT. THERE WAS NO DAMAGE TO THE STENT. BLUE FIBROUS FOREIGN MATTER WAS ON THE DISTAL SHAFT 7 CM FROM THE TIP. THERE WAS NO DAMAGE TO THE SDS. THE BLUE FIBERS INTERTWINED IN THE STENT AND ON THE SHAFT WERE MOST LIKELY FROM HANDLING THE DEVICE AND THE REPORTED INTERACTION WITH THE BLUE SURGICAL TOWEL. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WOULD NOT CROSS THE LESION. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED, DISTAL LEFT ANTERIOR DESCENDING ARTERY. USING A NON-BSC GUIDE CATHETER AND A NON-BSC GUIDE WIRE, THE PHYSICIAN ADVANCED THE 8MM X 2.25MM ION STENT DELIVERY SYSTEM (SDS) AND WAS NOT ABLE TO CROSS THE LESION. THE SDS WAS PLACED ON A BLUE SURGICAL TOWEL, BEFORE RE-INSERTING THE SDS THE PHYSICIAN NOTICED FIBERS FROM THE BLUE TOWEL HAD BECOME WRAPPED AROUND THE SDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CURRENT STATUS IS OKAY. RETURNED PRODUCT ANALYSIS REVEALED THE STENT MOVED ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902408220 14136538

    Patients

    Seq Age Sex Outcome Treatment
    1 PILOT 150 GUIDE WIRE| MEDTRONIC EBU 3.5 GUIDE CATHETER