BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2243761 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03774
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MONORAIL STENT DELIVERY SYSTEM (SDS) AND STENT. THE BALLOON WAS TIGHTLY FOLDED. THE FIRST TWO (2) ROWS ON THE PROXIMAL EDGE WERE STRETCHED AND FLARED AWAY FROM THE BALLOON. MULTIPLE ROWS ON THE DISTAL END OF THE STENT ARE STRETCHED DISTALLY, PAST THE DISTAL MARKERBAND TO THE TIP. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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

    SAME CASE AS MFR REPORT #: 2134265-2011-03775. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RCA (RIGHT CORONARY ARTERY). A 3.5X20MM ION STENT WAS PLACED SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A 3.0X28MM ION STENT TO THE MID RCA BUT WAS UNABLE TO CROSS THE LESION AND THE 3.0X28MM ION STENT BECAME STUCK ON THE IMPLANTED 3.5X20MM ION STENT. THE PHYSICIAN WAS ABLE TO REMOVE THE 3.0X28MM ION STENT; HOWEVER, BOTH STENTS WERE FLARED IN THE PROCESS. ANOTHER STENT WAS PLACED IN THE INTENDED LOCATION IN THE MID RCA. A THIRD STENT (3.5X20MM ION) WAS PLACED PROXIMALLY INTO THE OSTIUM, OVERLAPPING THE FLARED STENT STRUTS ON THE FIRST 3.5X20MM ION STENT. THE CASE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE PATIENT STATUS IS OKAY.

    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 H7493902428300 14046404

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention