BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3203053 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04414
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2008, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION 2) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 80% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75X20MM TAXUS PERSEUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. IN ADDITION, A NON-TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 80% STENOSIS WAS TREATED WITH PLACEMENT OF A TAXUS STENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED ON THE SAME DAY. THERE WAS 60% TO 70% PROXIMALLY NARROWING AT THE PREVIOUSLY DEPLOYED STUDY STENT, 60% TO 70% STENOSIS AT THE DISTAL EDGE OF THE STUDY STENT AND A DE-NOVO LESION WITH ALMOST 80% FOCAL STENOSIS AT THE ORIGIN OF THE POSTERIOR DESCENDING ARTERY (PDA). THIS WAS TREATED WITH PRE-DILATION AND PLACEMENT OF TWO PROMUS ELEMENT STENTS OF SIZE 2.5X8MM AND 2.75X12MM, AND A 2.75X18MM NON-BSC STENT, WITH 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302045 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 11842080

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R