BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 3030906 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01820
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 21, 2012
    Report Date
    March 4, 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2013-01817. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD TARGET VESSEL RESTENOSIS AND REQUIRED A TARGET LESION REVASCULARIZATION (TLR). IN (B)(6) 2007, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA). THE LESION WAS TREATED WITH PLACEMENT OF TWO TAXUS EXPRESS2 STENTS OF SIZE 3.00X24MM AND 3.50X24MM. THE PATIENT WAS DISCHARGED ON BAYASPIRIN AND PLAVIX. IN (B)(6) 2012, THE PATIENT HAD UNSTABLE ANGINA AND A 3.50X5.0MM LESION WITH MORE THAN 90% RESTENOSIS WAS FOUND IN THE MID RCA. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A TARGET LESION REVASCULARIZATION. THE LESION WAS DILATED WITH AN UNKNOWN BALLOON CATHETER WITH 0% RESIDUAL STENOSIS. THE EVENT WAS RESOLVED AND THE PATIENT HAD NO ANGINA SYMPTOMS AT 5-YEAR FOLLOW-UP IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2007, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT¿S QUALIFYING CONDITION AS STABLE ANGINA PECTORIS (CCS CLASS II). THE TARGET LESION WAS A DE NOVO LESION WITH 99% STENOSIS AND WAS 23.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.60 MM. LVEF WAS 71% AND TIMI FLOW GRADE WAS 1 PRE-INDEX PROCEDURE. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF TWO TAXUS EXPRESS2 STENTS WITH NO GAPS, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION AND TIMI FLOW GRADE IMPROVED TO 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135210 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897024300 9747894

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R