BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3833601 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02903
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 MDR ID# 2134265-2014-01260, 2134265-2014-01261, 2134265-2014-01262, 2134265-2014-03073. (B)(4) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND ANGINA OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA AND UNSTABLE ANGINA PECTORIS AND WAS REFERRED FOR CARDIAC CATHETERIZATION. A 2.5MM X 4MM ION¿ STENT WAS IMPLANTED AT THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). IN (B)(6) 2014, THE PATIENT WAS PRESENTED WITH UNSTABLE ANGINA AND WAS SUBSEQUENTLY HOSPITALISED. THE MILD ISR OF THE PREVIOUSLY PLACED TAXUS STENT IN PROXIMAL RCA AND THE 100% STENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS IN THE PROXIMAL RCA EXTENDING TO DISTAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3 NON-BSC DRUG ELUTING STENTS (DES). FOLLOWING POST DILATATION. RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, A 90-95% ISR OF PREVIOUSLY PLACED ION NON-STUDY STENT IN DISTAL LEFT CIRCUMFLEX (LCX) WAS TREATED WITH PLACEMENT OF 2.75 X 23 MM NON-BSC DES. MEDICATION WAS GIVEN TO TREAT THIS EVENT. THE EVENT IS CONSIDERED RECOVERING/RESOLVING. TWO DAYS POST HOSPITALIZATION, SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310442 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R