BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3201617 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04392
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATION 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MDR ID# 2134265-2013-02117. SAME PATIENT AS MDR ID# 2134265-2013-02116. SAME CASE AS MDR ID# 2134265-2013-04393. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IN-STENT RESTENOSIS OCCURRED. (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 70% STENOSED AND 13MM LONG TARGET LESION WAS AN IN-STENT RESTENOTIC LESION OF AN UNKNOWN MANUFACTURER¿S STENT WITH A POSSIBLE THROMBUS IN THE DISTAL SEGMENT OF THE SUPERIOR VEIN GRAFT TO THE 1ST DIAGONAL ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50X16MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 70% STENOSED AND 13MM LONG SECOND TARGET LESION WAS AN IN-STENT RESTENOTIC LESION OF AN UNKNOWN MANUFACTURER¿S STENT WITH A POSSIBLE THROMBUS IN THE 1ST DIAGONAL WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.25X16MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. (B)(6) 2011, 2 TAXUS LIBERTE STENTS WERE DEPLOYED IN THE OSTIAL SUPERIOR VEIN GRAFT TO THE OBTUSE MARGINAL AND THE DISTAL SUPERIOR VEIN GRAFT TO THE OBTUSE MARGINAL. IN (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF LEFT SIDED CHEST PAIN WITH NO RADIATION, SHORTNESS OF BREATH ON EXERTION AND REST; THE PATIENT ALSO HAD ORTHOPNEA, PAROXYSMAL NOCTURNAL DYSPNEA AND WHEEZE WITH YELLOW SPUTUM. ELECTROCARDIOGRAPHY REVEALED ST CHANGES WITH FIRST DEGREE ATRIOVENTRICULAR BLOCK. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHIC RESULTS REVEALED FOCAL DISTAL IN-STENT RESTENOSIS OF THE 2.50X16MM TAXUS LIBERTE STUDY STENT PLACED IN THE SUPERIOR VEIN GRAFT TO THE 1ST DIAGONAL ARTERY. A TOTAL OCCLUSION IN THE PROXIMAL CIRCUMFLEX WAS TREATED WITH BALLOON ANGIOPLASTY WITH SEQUENTIAL BALLOON INFLATIONS WITH 20%- 30% RESIDUAL STENOSIS. ATTEMPTS TO PASS UNKNOWN MANUFACTURER¿S STENTS INTO THE CIRCUMFLEX FAILED DUE TO THE HEAVILY CALCIFIED LESION. SUPERIOR VEIN GRAFTS WERE NOT ADDRESSED TO AVOID CONTRAST INDUCED NEPHROPATHY. EIGHT DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED WITH ASPIRIN AND PLAVIX. ELEVEN DAYS POST DISCHARGE THE PATIENT PRESENTED WITH ANGINA AND HAD SIGNIFICANT LESIONS IN THE SAPHENOUS VEIN GRAFTS TO THE FIRST DIAGONAL AND OBTUSE MARGINAL ARTERIES. THE PATIENT WAS DIAGNOSED WITH WORSENED CORONARY ARTERY DISEASE AND TARGET VESSEL REVASCULARIZATION WAS PERFORMED. THE SAME DAY THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS. IN (B)(6) 2013 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH THE WORSENING SYMPTOMS OF CORONARY ARTERY DISEASE AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION. IT WAS UNSPECIFIED HOW THE PATIENT WAS TREATED. THREE DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON SAME DAY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2011, THE PATIENT RETURNED TO THE CATH LAB AND WAS SCHEDULED FOR CARDIAC CATHETERIZATION TO THE SVG-OBTUSE MARGINAL (OM) GRAFT. A 3RD DE-NOVO TARGET LESION WAS LOCATED IN THE DISTAL SVG OF THE OBTUSE MARGINAL WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 16 MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE NEXT DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. A 4TH DE-NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL SVG TO 1ST OM WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 3.50X16 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION THE RESIDUAL STENOSIS WAS 10%. IN (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH ACUTE ON CHRONIC RENAL FAILURE. A 90% FOCAL IN-STENT RESTENOSIS WAS TREATED IN THE SVG TO 1ST OM WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.5X15MM NON BSC STENT RESULTING IN 0% RESIDUAL STENOSIS. REVASCULARIZATION WAS ALSO PERFORMED ON AN 80% FOCAL IN-STENT RESTENOSIS IN THE OSTIUM OF THE SVG TO OM1. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 4.00 X 28 MM ION DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION REVASCULARIZATION WAS PERFORMED ON A 90% FOCAL IN-STENT RESTENOSIS IN SVG TO 1ST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.50X16MM ION STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SAME DAY THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX. IN (B)(6) 2013, THE PATIENT DEVELOPED SUBSTERNAL CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH. AT THE TIME OF THE EVENT THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. TROPONIN LEVELS WERE NOTED TO BE ELEVATED. DURING THE COURSE OF THE HOSPITALIZATION, THE PATIENT WAS TREATED MEDICALLY. THE PATIENT WAS ADVISED FOR CARDIAC REHABILITATION. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303359 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616350 13333369

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention