BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3102239 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03143
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-03146. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT RESTENOSIS OCCURRED. (B)(6) 2008 - THE PATIENT PRESENTED WITH A TWO WEEK HISTORY OF CHEST PAIN RADIATING TO BOTH ARMS ASSOCIATED WITH SHORTNESS OF BREATH. WHICH THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA. THE 75% STENOSED TARGET LESION WAS 28.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM, LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PRE DILATED THE LESION WITH AN UNKNOWN BALLOON CATHETER AND PLACED TWO (3.50 X 32 AND 3.50 X 12 MM), TAXUS ELEMENT STUDY STENTS, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. (B)(6) 2013, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST DISCOMFORT ASSOCIATED WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED ON SAME DAY. ANGIOGRAPHY REVEALED 90% INSTENT RESTENOSIS OF TAXUS ELEMENT STUDY STENT IN MID RCA, WHICH WAS TREATED WITH THE PLACEMENT OF A NON BSC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204021 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 11069350

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention