BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2183100 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03124
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    April 13, 2011
    Report Date
    July 4, 2011
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH CCS CLASS II STABLE ANGINA AND TIMI 3 FLOW AT THE LESION. THE INDEX PROCEDURE TARGET LESION WAS A 3.2X12MM 90% STENOSIS OF THE PROXIMAL RCA. TREATMENT CONSISTED OF DIRECT PLACEMENT OF A 3.5X16MM TAXUS EXPRESS2 STENT RESULTING IN 25% RESIDUAL STENOSIS. TIMI 3 FLOW REMAINED THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY ON BAYASPIRIN AND PANALDINE. AT THE REINTERVENTION IN (B)(6) 2011, THE 90% STENOSIS OF THE PROXIMAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY. TIMI 3 FLOW WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY POST REINTERVENTION.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. IN (B)(6) 2008, DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS EXPRESS2 STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2011, A CORONARY ANGIOGRAM REVEALED RESTENOSIS IN THE PROXIMAL RCA. THE 90% STENOSED TARGET LESION WAS 3.0MM IN DIAMETER AND 13MM LONG. THE PATIENT HAD NO ANGINAL SYMPTOMS. IN (B)(6) 2011, AN INTERVENTION WAS PERFORMED. THE LESION WAS DILATED WITH AN UNKNOWN BALLOON. RESIDUAL STENOSIS WAS 25%. THE PATIENT HAD NO ISCHEMIC SYMPTOMS AT THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016350 11356251

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention