BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2962565 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00734
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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

    IT WAS PREVIOUSLY REPORTED THE PATIENT HAD TWO UNKNOWN TAXUS STENTS IMPLANTED. WHICH HAS BEEN CORRECTED TO THREE UNKNOWN TAXUS STENTS, TWO WERE PLACED IN THE MID RIGHT CORONARY ARTERY (RCA) IN (B)(6) 2005. THE PATIENT THEN HAD ANOTHER PLACED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY IN (B)(6) 2005. THE EVENT DATE WAS REPORTED AS TAKING PLACE IN (B)(6) 2010. THIS HAS BEEN CORRECTED TO (B)(6) 2013.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR# 2134265-2013-00734. SAME PATIENT AS MDR# 2134265-2013-00740. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION, IN-STENT RESTENOSIS, AND ANGINA. THE PATIENT HAD TWO UNKNOWN TAXUS STENTS IMPLANTED. ONE WAS PLACED IN THE MID RIGHT CORONARY ARTERY (RCA) AND THE OTHER WAS PLACED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. DEC-2010 - THE PATIENT PRESENTED WITH UNSTABLE ANGINA, DIAGNOSED AS A MYOCARDIAL INFARCTION. CORONARY ANGIOGRAPHY REVEALED 90% IN-STENT RESTENOSIS OF BOTH 2005 PREVIOUSLY PLACED STENTS. THE PHYSICIAN TREATED THE IN-STENT RESTENOSIS OF A PREVIOUSLY DEPLOYED UNKNOWN TAXUS STENT (IN 2005), LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA), WITH DIRECT STENT PLACEMENT OF 3 X 20 MM PROMUS ELEMENT (PE) PLUS STENT, WITH 0% RESIDUAL STENOSIS. TREATMENT OF THE DISTAL LAD IS UNKNOWN. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND CLOPIDOGREL. SIX DAYS LATER THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. CORONARY ANGIOGRAPHY REVEALED 100% PROXIMAL OCCLUSION IN THE 1ST DIAGONAL AND 75% DISTAL IN-STENT RESTENOSIS LOCATED IN THE DISTAL LAD, WITHIN THE PREVIOUSLY DEPLOYED UNKNOWN TAXUS STENT (IN 2005). THE PHYSICIAN TREATED THE IN-STENT RESTENOSIS WITH THE PLACEMENT OF 2.5 X 28 MM PROMUS STENT, WITH 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64579 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR