BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 3122443 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03226
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 22, 2012
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR# 2134265-2013-03227. PATIENT HAD TWO TAXUS EXPRESS2 STENTS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) IN (B)(6) 2008. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS AND STABLE ANGINA. (B)(6) 2012 - THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS HOSPITALIZED. CORONARY ANGIOGRAPH REVEALED THAT THE MID LAD WAS STENOSED. (B)(6) 2012. THE PATIENT PRESENTED WITH STABLE ANGINA. THE 75% STENOSED TARGET LESION WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM, IN THE MID LAD. THE PHYSICIAN IMPLANTED AN UNSPECIFIED PROMUS ELEMENT STENT IN THE LESION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED: IN (B)(6) 2008, A DE-NOVO LESION LOCATED IN THE PROX LAD WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM, A LENGTH OF 20.0 MM AND 90% STENOSIS WAS TREATED WITH PRE-DILATATION, DEPLOYMENT OF A 2.50X24 MM TAXUS EXPRESS 2 STENT AND A 3.50X12 MM TAXUS EXPRESS 2 STENT AND POST-DILATATION. RESIDUAL STENOSIS BECAME 25% AND TIMI FLOW GRADE REMAINED 3. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO COMPLICATIONS ON PLAVIX AND BAYASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223619 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897024250 11312024

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention