BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2232529 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03687
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 10, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MONORAIL STENT DELIVERY SYSTEM (SDS) WITHOUT THE STENT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON, CENTERED BETWEEN THE MARKERBANDS. THE STRUT IMPRESSIONS ON THE BALLOON CONFIRMED THAT THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE SDS DURING MANUFACTURING. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). TWO UNSUCCESSFUL ATTEMPTS WERE MADE TO IVUS THE RCA WITH TWO DIFFERENT ATLANTIS SR PRO CATHETERS, THE THIRD ATTEMPT WITH ANOTHER ATLANTIS SR PRO WAS SUCCESSFUL. THE LESION WAS THEN DILATED WITH A 3.0X15MM AND 3.5X15MM APEX BALLOONS. FOLLOWING DILATION THE PHYSICIAN ADVANCED THE 4.0X12MM ION MR STENT SYSTEM AND THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN USED A 1.5X15MM BALLOON TO PULL THE DISLODGED STENT BACK INTO THE GUIDE CATHETER, THEY WERE UNABLE TO LOCATE THE DISLODGED STENT ON THE TABLE OR IN THE PATIENT. PROCEDURE WAS COMPLETED WITH A 4.0X20MM ION STENT AND WAS POST DILATED WITH A 4.0MM NC QUANTUM APEX BALLOON WITH GOOD RESULT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). TWO UNSUCCESSFUL ATTEMPTS WERE MADE TO IVUS THE RCA WITH TWO DIFFERENT ATLANTIS SR PRO CATHETERS, THE THIRD ATTEMPT WITH ANOTHER ATLANTIS SR PRO WAS SUCCESSFUL. THE LESION WAS THEN DILATED WITH A 3.0X15MM AND 3.5X15MM APEX BALLOONS. FOLLOWING DILATION THE PHYSICIAN ADVANCED THE 4.0X12MM ION MR STENT SYSTEM AND THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN USED A 1.5X15MM BALLOON TO PULL THE DISLODGED STENT BACK INTO THE GUIDE CATHETER, THEY WERE UNABLE TO LOCATE THE DISLODGED STENT ON THE TABLE OR IN THE PATIENT. PROCEDURE WAS COMPLETED WITH A 4.0X20MM ION STENT AND WAS POST DILATED WITH A 4.0MM NC QUANTUM APEX BALLOON WITH GOOD RESULT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902412400 14124855

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention TWO IVUS IMAGING CATHETERS