BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2792670 · Received October 16, 2012

    Report

    Report Number
    2134265-2012-06213
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT REQUIRED A RE-INTERVENTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM PERSEUS STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH SYMPTOMS OF PROGRESSIVE ANGINA. CARDIAC CATHETERIZATION REVEALED 95% STENOSIS IN THE MID LAD AND THE STUDY STENT WAS PATENT. THE PATIENT UNDERWENT A NUCLEAR STRESS TEST SUGGESTING INTRASEPTAL ISCHEMIA AND WITH AN EJECTION FRACTION OF 62%. IN ADDITION, THE PATIENT IS KNOWN TO HAVE TRANSIENT ISCHEMIC DILATATION. THE 95% STENOSIS LOCATED IN THE MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. FOLLOWING INTERVENTION, A 2.50 X 16 MM ION STENT AND A 2.50 X 14 MM NON BSC STENT WERE ATTEMPTED TO BE PLACED, HOWEVER BOTH THE STENTS COULD NOT BE PLACED SECONDARY TO MARKED CALCIFICATION AND TORTOSITY OF PROXIMAL LAD. THE PATIENT WAS TREATED WITH AGGRESSIVE MEDICAL THERAPY. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    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 UNK692 11068829

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention