BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2122281 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02335
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DATE OF BIRTH, PATIENT SEX, DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY, RELEVANT TESTS/LAB DATA. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-02337. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT MIGRATION OCCURRED. A 20X4.0MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO AN UNSPECIFIED LESION. THE STENT WAS DEPLOYED AT SUFFICIENT ATMOSPHERES. HOWEVER, WHILE POST DILATING THE STENT IT MOVED TO AN UNFAVORABLE SPOT. IT WAS REPORTED THAT A 12X4.0MM ION SDS WAS ALSO ADVANCED DURING THE CASE. WHEN POST DILATING THE STENT, IT ALSO MOVED TO AN UNFAVORABLE LOCATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ACCESS WAS OBTAINED THROUGH THE LEFT FEMORAL ARTERY. THE 60-80% STENOSED TARGET LESION WAS LOCATED IN THE ECTATIC AND PATULOUS SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL. A NON-BSC (B)(4) GUIDE CATHETER ENGAGED THE OSTIUM OF THE VEIN GRAFT. A 0.014 LUGE GUIDE WIRE AND NON-BSC EMBOLIC PROTECTION WIRE WERE PLACED DISTALLY BEFORE ADVANCING A 4.0X16MM ION STENT DELIVERY SYSTEM (SDS) AND DEPLOYING THE STENT IN THE MID GRAFT. A 4.0X20MM ION STENT WAS THEN PLACED PROXIMALLY. NEXT, ATTEMPTS WERE MADE TO PASS A 3.5X16MM ION SDS DISTALLY BUT IT COULD NOT TRAVERSE THE MID STENT. THE MID STENT WAS GOING TO BE POST DILATED WITH A 4.0MM NON-BSC BALLOON, HOWEVER WHILE ADVANCING THE BALLOON CATHETER, THE PROXIMALLY PLACED STENT MIGRATED AND PUSHED INTO THE STENT IN THE MID VESSEL. THE BALLOON POST DILATED THE 4.0X20MM ION STENT AT THE LOCATION THAT IT MIGRATED. ALSO, THERE WAS EVIDENCE OF PLAQUE PROLAPSE AT THE STENT SEGMENT. A PT GRAPHIX GUIDE WIRE CROSSED THE STENTED SEGMENT AND A 4.0X12MM ION STENT WAS ADVANCED AND DEPLOYED AT THE PROXIMAL ASPECT WHERE THE STENT PROLAPSE WAS NOTED. HOWEVER, UPON WITHDRAWAL OF THE STENT DELIVERY BALLOON, THE 12X4.0MM STENT MIGRATED PROXIMALLY. A 5.0X8MM NON-BSC BALLOON PULLED THE STENT BACK INTO THE PROXIMAL PART OF THE GRAFT AND IT WAS DILATED AND DEPLOYED IN A STABLE POSITION. NO ADDITIONAL INTERVENTION WAS PERFORMED.

    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 H7493902420400 14070880

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other