BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1913125 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05257
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    January 12, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM - TARGET LESION CORRECTED FROM PROXIMAL LCX ARTERY TO DISTAL LCX ARTERY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4): AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00172. IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED THE 100% STENOSED, 3.0MM REFERENCE DIAMETER TARGET LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF TWO OVERLAPPING TAXUS LIBERTE STENTS (3.0X16MM, 2.5X32MM) AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATION 2 DAYS POST THE INDEX PROCEDURE ON ASPIRIN AND TICLID. REVASCULARIZATION WAS PERFORMED IN THE 75% STENOSED, 2.5X40MM REFERENCED DISTAL LCX ARTERY. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE PLACED AN UNSPECIFIED (B)(4) STENT IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. IN (B)(6) 2010, WITH NO ISCHEMIC SYMPTOMS, ANGIOGRAPHY REVEALED A 75% RESTENOSED, 2.5X40MM LENGTH LESION LOCATED IN THE PROXIMAL LCX ARTERY. THREE DAYS LATER A TARGET LESION REVASCULARIZATION PROCEDURE TREATED THE LESION WITH ANGIOPLASTY RESULTING IN A 25% RESIDUAL STENOSIS. TIMI 3 FLOW WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY IN IMPROVED CONDITION. NO ANGINA WAS CONFIRMED AT THE 1 YEAR FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 2.5X32MM TAXUS LIBERTE