BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1885522 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-04879
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    June 7, 2010
    Report Date
    October 6, 2010
    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 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. 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

    THE STENT IMPLANTED IN THE PROX RCA CORRECTED TO BE A NON BSC DEVICE INSTEAD OF A TAXUS STENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENOSIS WAS DISCOVERED. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS LOCATED IN THE RIGHT ATRIOVENTRICULAR BRANCH (R-PAV). THE PHYSICIAN IMPLANTED A 2.50X16MM TAXUS EXPRESS2 STENT IN THE TARGET LESION. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED IN (B)(6) 2010, AND STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WAS FOUND. THE PATIENT HAD NO ISCHEMIC SYMPTOMS AT THE TIME OF THE EVENT THE LESION WAS 4.00MM, 90% STENOSED AND 18.0MM LONG. A BARE METAL STENT WAS IMPLANTED IN THE PROX RCA OF UNKNOWN SIZE. POST PROCEDURE THE STENOSIS WAS 25%. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE STENOSIS TO THE TAXUS STENT IS POSSIBLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PCI WAS PERFORMED TO TREAT TWO LESIONS LOCATED IN MID RIGHT CORONARY ARTERY (MID RCA) AND RIGHT ATRIOVENTRICULAR BRANCH (R-PAV). THE DE NOVO LESION WITH REFERENCE VESSEL DIAMETER OF 2.60 MM, LENGTH OF 10.0 MM, AND 90% STENOSIS LOCATED IN R-PAV WAS TREATED WITH PRE-DILATATION, AND DEPLOYMENT OF A 2.50 X 16 MM TAXUS EXPRESS2 STENT, AND POST-DILATATION. RESIDUAL STENOSIS BECAME 25%. TIMI-3 FLOW KEPT THROUGH THE INDEX PROCEDURE. THE LESION IN MID RCA WAS TREATED WITH DEPLOYMENT OF NON BSC STENT. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS THE NEXT DAY ON BYASPIRIN AND PLAVIX. SOME 963 DAYS POST-INDEX PROCEDURE, STENOSIS WITHOUT ISCHEMIC SYMPTOMS WAS CONFIRMED IN PROX RCA WHERE A NON BSC STENT HAD BEEN IMPLANTED. TIMI-3 FLOW KEPT THROUGH THE PCI PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016250

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention