BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2123873 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02182
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS. THE INDEX PROCEDURE PLACED A 2.5X16MM ION STENT IN THE PROXIMAL TO MID LEFT CIRCUMFLEX (LCX) ARTERY. SIX DAYS LATER, THE PATIENT UNDERWENT A STAGED PROCEDURE TREATING THE RIGHT CORONARY ARTERY WITH NO COMPLICATIONS. LATER THAT NIGHT WHILE STILL IN THE HOSPITAL, THE PATIENT EXPERIENCED THROMBOSIS OF THE 2.5X16MM ION STENT LOCATED IN THE LCX ARTERY. TREATMENT CONSISTED OF A THROMBECTOMY, ANGIOPLASTY, THE PLACEMENT OF A NON BSC 2.5X23MM STENT DISTALLY OVERLAPPING THE PREVIOUSLY PLACED STENT. POST DILATION WAS PERFORMED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS ON ANTIPLATELET THERAPY AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS. THE INDEX PROCEDURE PLACED A 2.5X16MM ION STENT IN THE PROXIMAL TO MID LEFT CIRCUMFLEX (LCX) ARTERY. SIX DAYS LATER, THE PATIENT UNDERWENT A STAGED PROCEDURE TREATING THE RIGHT CORONARY ARTERY WITH NO COMPLICATIONS. LATER THAT NIGHT WHILE STILL IN THE HOSPITAL, THE PATIENT EXPERIENCED THROMBOSIS OF THE 2.5X16MM ION STENT LOCATED IN THE LCX ARTERY. TREATMENT CONSISTED OF A THROMBECTOMY, ANGIOPLASTY, THE PLACEMENT OF A NON BSC 2.5X23MM STENT DISTALLY OVERLAPPING THE PREVIOUSLY PLACED STENT. POST DILATION WAS PERFORMED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS ON ANTIPLATELET THERAPY AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    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 H7493902416250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention