BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882621 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08216
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 3, 2012
    Report Date
    December 4, 2012
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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) STUDY. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, SILENT ISCHEMIA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2008, A TAXUS EXPRESS 2 STENT WAS IMPLANTED IN A LESION LOCATED IN THE DISTAL CIRCUMFLEX (CX). IN (B)(6) 2012, CORONARY ANGIOGRAPHY REVEALED 75% RESTENOSIS IN THE DISTAL CX. THE RESTENOSIS WAS 30 MM LONG WITH A DIAMETER OF 2.75 MM. THE SUBJECT EXPERIENCED SILENT ISCHEMIA AND THE LESION WAS TREATED WITH DILATATION USING A NON-BSC BALLOON CATHETER AND TWO NON-BSC STENTS (2.5 X 18 AND 2.75 X 14) WERE IMPLANTED. IN ADDITION, 75% STENOSIS WAS NOTED IN THE LEFT ATRIOVENTRICULAR ARTERY. THE STENOSIS WAS 13 MM LONG WITH A DIAMETER OF 2.5MM AND WAS TREATED WITH DILATATION USING AN UNKNOWN BALLOON CATHETER AND THE PLACEMENT OF A 2.5 X 14 NON-BSC STENT. IT WAS ALSO REPORTED THAT AN ARCTATION OCCURRED. ANTIPLATELET MEDICATION INCLUDED HEPARIN7000 U (B)(6) 2012, HEPARIN 5000U (B)(6) 2012, PLAVIX 75MG, AND BAYASPIRIN 100MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention