BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2133280 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02403
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE TAXUS ELEMENT/ ION STENT DELIVERY SYSTEM (SDS) WITH STENT WAS RECEIVED IN A TAXUS ELEMENT/ ION SHELF BOX WITH NO OTHER ORIGINAL PACKAGING. THERE WAS BLOOD IN THE DISTAL END OF THE WIRE LUMEN. THE MOUTH OF THE DISTAL TIP WAS SLIGHTLY BENT AND FLATTENED. THE FIRST DISTAL ROW OF STRUTS WERE STRETCHED OVER THE DISTAL MARKER BAND BUT WAS STILL PROXIMAL TO THE DISTAL BALLOON CONE. THERE WERE SEVERAL OTHER BENT, STRETCHED AND FLARED STRUTS IN THE FIRST SIX (6) DISTAL ROWS OF STENT STRUTS. THERE WAS ONE (1) FLARED STRUT AND TWO (2) SLIGHTLY LIFTED STRUTS IN THE ELEVENTH DISTAL ROW. MAGNIFIED INSPECTION CONFIRMED THAT THE PROXIMAL END OF THE STENT DID NOT MOVE FROM IT'S AS-MANUFACTURED POSITION. THERE WAS NO OTHER DAMAGE TO THE SDS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-02405. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION WITH A 3.00X28MM ION STENT; HOWEVER, THE STENT STRUT BECAME FLARED DURING THE ATTEMPT. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION WITH ANOTHER 3.0X28MM ION STENT AND THAT STENT BECAME DAMAGED AS WELL. THE SDS WAS REMOVED FROM THE PATIENT AND THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. THE PHYSICIAN WAS THEN ABLE TO CROSS THE LESION WITH A 3.0X28MM NON BSC STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NON BSC STENT AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CURRENT CONDITION IS OKAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-02405. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION WITH A 3.00X28MM ION STENT; HOWEVER, THE STENT STRUT BECAME FLARED DURING THE ATTEMPT. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION WITH ANOTHER 3.0X28MM ION STENT AND THAT STENT BECAME DAMAGED AS WELL. THE SDS WAS REMOVED FROM THE PATIENT AND THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. THE PHYSICIAN WAS THEN ABLE TO CROSS THE LESION WITH A 3.0X28MM NON BSC STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NON BSC STENT AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CURRENT CONDITION 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 64 YR