BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2880490 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-08193
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 30, 2012
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). 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

    (B)(4). IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, LONGITUDINAL TISSUE SHIFT OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED TO EMERGENCY WITH ABDOMINAL PAIN RADIATING TO THE BACK. THE PATIENT HAD ELEVATED TROPONIN VALUES CONSISTENT WITH A MYOCARDIAL INFARCTION. AN ANGIOGRAM PERFORMED THREE DAYS LATER REVEALED 70% STENOSIS IN THE LIMA TO LAD (LEFT INTERNAL MAMMARY ARTERY TO LEFT ANTERIOR DESCENDING ARTERY). SEVENTY PERCENT DISTAL STENOSIS WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.5 X 20 MM ION STENT. POST DEPLOYMENT, THE PROXIMAL PORTION OF THE STENT APPEARED HAZY. THE SITE CONFIRMED THAT THE HAZINESS OF THE STENT WAS DUE TO 'LONGITUDINAL TISSUE SHIFT'. IC NITRO WAS ADMINISTERED AND A 2.5 X 8 MM ION STENT WAS DEPLOYED TO COVER THE HAZY SEGMENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE FOLLOWING DAY.

    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 UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R