BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 2500406 · Received March 22, 2012

    Report

    Report Number
    2134265-2012-01515
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MR STENT DELIVERY SYSTEM (SDS) WITH GUIDE WIRE. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON. BACKLOADED THE RETURNED 0.014 INCH GUIDE WIRE THROUGH THE DEVICE LUMEN WITH NO RESTRICTIONS. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CATHETER FROZE ON WIRE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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 MDR ID# 2134265-2012-01501. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DELIVERY SYSTEM WAS STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED CALCIFIED LESION. THE 3.0 X 38MM ION MR STENT DELIVERY SYSTEM WAS ADVANCED OVER A NON BSC GUIDE WIRE AND FROZE ON THE WIRE. THE GUIDE WIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER. ANOTHER NON BSC GUIDE WAS INTRODUCED AND A 3.0 X 38MM STENT DELIVERY SYSTEM WAS ADVANCED AND UPON RESISTANCE THE SHAFT BROKE. THE PROCEDURE WAS THEN COMPLETED WITH A 3.5 X 38MM ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2012-01501. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DELIVERY SYSTEM WAS STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED CALCIFIED LESION. THE 3.0 X 38MM ION MR STENT DELIVERY SYSTEM WAS ADVANCED OVER A NON BSC GUIDE WIRE AND FROZE ON THE WIRE. THE GUIDE WIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER. ANOTHER NON BSC GUIDE WAS INTRODUCED AND A 3.0 X 38MM STENT DELIVERY SYSTEM WAS ADVANCED AND UPON RESISTANCE THE SHAFT BROKE. THE PROCEDURE WAS THEN COMPLETED WITH A 3.5 X 38MM ION STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438300 14632213

    Patients

    Seq Age Sex Outcome Treatment
    1