BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2870945 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07433
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    April 16, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). 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

    (B)(4) STUDY. SAME CASE AS MDR ID#2134265-2012-07434 AND 2134265-2012-07438. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, ANGINA, SEVERE CORONARY ARTERY DISEASE, DYSPNEA, NAUSEA, STENOSIS, AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2011, THE SUBJECT PRESENTED WITH LEFT-SIDED NUMBNESS AND CHEST PAIN. CT AND MRI OF HEAD WERE UNREMARKABLE. ECG REVEALED NORMAL SINUS RHYTHM AND CARDIAC ENZYMES WERE FOUND TO BE NEGATIVE. STRESS TEST WAS ABNORMAL WITH MEDIUM-SIZED LATERAL AND INFERIOR LATERAL MYOCARDIAL ISCHEMIA. THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED TWO TARGET LESIONS. TARGET LESION #1 WAS AN 80% STENOSED DE NOVO LESION,WITH PRE-EXISTING THROMBUS, LOCATED IN THE MID PORTION OF THE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE LESION WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM AND TREATED WITH DIRECT STENT PLACEMENT USING A 4.00 X 38 MM TAXUS LIBERTE STENT. POST-DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS A 70% STENOSED DE-NOVO LESION, LOCATED IN THE DISTAL PORTION OF THE SVG TO R-PDA. THIS LESION WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM AND TREATED WITH DIRECT STENT PLACEMENT USING A 4.00 X 24 MM TAXUS LIBERTE STENT, OVERLAPPING DISTALLY WITH ANOTHER 4.00 X 32 MM TAXUS LIBERTE STENT AND PROXIMALLY WITH THE PREVIOUSLY DEPLOYED 4.00 X 38 MM STENT, DEPLOYED IN TARGET LESION #1. RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL, THE FOLLOWING DAY. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH SUB-STERNAL CHEST PAIN,RADIATING TO THE LEFT ARM, ASSOCIATED WITH SHORTNESS OF BREATH AND NAUSEA. THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED 90% STENOSIS IN THE MID-SEGMENT OF THE R-PDA, "PROXIMAL TO SVG INSERTION SITE." THE STENOSIS WAS TREATED WITH PLACEMENT OF A 2.5 X 24 MM NON-BSC STENT. FOLLOWING BALLOON ANGIOPLASTY, RESIDUAL STENOSIS WAS 0%. IN ADDITION, THE 80% STENOSIS IN THE SVG TO R-PDA WAS TREATED WITH PLACEMENT OF A FOUR NON-BSC STENTS (4.00 X 28 MM, TWO 4.00 X 38 MM, AND A 3.5 X 15 MM) WITH 0% RESIDUAL STENOSIS. AT THE TIME OF EVENT, THE SUBJECT WAS ON ASPIRIN AND STUDY DRUG (WHICH WAS DISCONTINUED). THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL, TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632400 13415715

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention