BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 3052477 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02154
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 MDR ID# 2134265-2013-02155. SAME CASE AS MDR ID# 2134265-2013-02163. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT REQUIRED REINTERVENTION. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO CHEST PAIN AND A POSITIVE STRESS TEST. CARDIAC CATHETERIZATION WAS RECOMMENDED. A 75% STENOSED AND 36 MM LONG DE-NOVO #1 TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE #1 TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X38 MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 90% STENOSED AND 36 MM LONG DE-NOVO #2 TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE #2 TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75X38 MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 80% STENOSED AND 30 MM LONG DE-NOVO #3 TARGET LESION WAS LOCATED IN THE PROXIMAL RCA WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE #3 TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.5X15 MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 90% STENOSED NON TARGETED LESION IN THE RIGHT POSTEROLATERAL DESCENDING ARTERY WAS TREATED WITH PLACEMENT OF A 2.5X15 MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH RECURRENT CHEST DISCOMFORT AND PROGRESSIVE DYSPNEA ON STRESS. CARDIAC CATHETERIZATION WAS RECOMMENDED. AN 80% STENOSED LESION LOCATED IN PROXIMAL RCA TO MID RCA WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X38 MM PROMUS STENT, RESULTING ON 0% RESIDUAL STENOSIS. DURING TREATMENT THE PROXIMAL RCA RECEIVED BALLOON ANGIOPLASTY DUE TO DIFFICULTY STENTING THE 75% STENOSED LESION IN THE PROXIMAL RCA DUE TO "INSUFFICIENT BACK UP". A 75% STENOSED LESION IN THE DISTAL RCA TO THE 1ST RIGHT POSTEROLATERAL DESCENDING ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75X12 MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 95% STENOSED LESION IN THE SUPERIOR VEIN GRAFT TO THE 1ST DIAGONAL WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.5X38 MM PROMUS STENT OVERLAPPING A 3.5X16 MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION A 75% STENOSED LESION IN THE RIGHT POSTEROLATERAL DESCENDING ARTERY WAS TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 25% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154476 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893738270 13712311

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention