BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2203417 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03244
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 #: 2134265-2011-03243. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN A VEIN GRAFT TO THE RIGHT CORONARY ARTERY (RCA). TREATMENT PLACED A FILTERWIRE EZ, PRE-DILATED WITH A 3.5X20MM QUANTUM APEX BALLOON WITH 6 INFLATIONS TO A MAXIMUM PRESSURE OF 10 ATM'S AND PLACED A 4.0X38MM ION STENT DEPLOYED AT 12 ATM'S FOR 16 SECONDS WITH RE-INFLATION AT 14ATM'S FOR 10 SECONDS. ANGIOGRAPHY WAS THEN PERFORMED IN SINGLE VIEW. TWO ADDITIONAL 4.0X38MM ION STENTS WERE THEN IMPLANTED IN THE TARGET LESION DEPLOYED AT 12 & 16 ATM'S WITH RE-INFLATIONS AT 14 & 16 ATM'S. ANGIOGRAPHY WAS AGAIN PERFORMED AND A 4.0X16MM ION STENT WAS DEPLOYED IN THE TARGET LESION AT 16 ATM'S FOR 14 SECONDS WITH RE-INFLATIONS AT 18 & 16 ATM'S. THE AREA WAS POST DILATED WITH A 4.5X20MM NC QUANTUM APEX BALLOON WITH 10 INFLATIONS TO A MAXIMUM PRESSURE OF 14 ATM'S WITH GOOD RESULT. THE FILTERWIRE EZ RETRIEVAL SHEATH WAS THEN ADVANCED BUT SNAGGED AND CRUMPLED THE FIRST 4.0X38MM ION STENT IMPLANTED. THE PHYSICIAN WENT BACK IN AND POST DILATED THE AREA WITH A 4.5X20MM NC QUANTUM APEX BALLOON WITH 3 INFLATIONS AT 12 ATM'S AND THEN DELIVERED A 4.0X8.0MM ION STENT INFLATED TWICE AT 20 ATM'S OVER THE TOP OF THE PREVIOUSLY PLACED STENT. A 4.5X20MM NC QUANTUM APEX BALLOON WAS THEN ADVANCED AND INFLATED FOUR TIMES AT 16 ATM'S WITH GOOD RESULT. A BENT TIP RETRIEVAL SHEATH WAS USED TO REMOVE THE FILTERWIRE EZ. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    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 UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FILTER WIRE EZ| 4.0X16MM ION STENT| 4.0X38MM ION STENT| 4.0X38MM ION STENT