BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3587543 · Received January 22, 2014

    Report

    Report Number
    2134265-2013-09813
    Event Type
    Death
    Date Received
    January 22, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID 2134265-2013-09812, 2134265-2013-09811, 213465-2013-09794, 2134265-2013-09795. (B)(4). IT WAS REPORTED THAT MYOCARDIAL INFARCTION, THROMBOSIS, AND DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED 3-5 DAYS HISTORY OF CHEST PAIN ASSOCIATED WITH NAUSEA AND SHORTNESS OF BREATH AND WAS DIAGNOSED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIIB). CARDIAC CATHETERIZATION WAS RECOMMENDED AND THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 44 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50 X 38 MM AND 3.50 X 8 MM TAXUS LIBERTE STENTS, WITH 9% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID RCA WITH 80% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 20 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 9%. TARGET LESION #3 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WITH 80% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED DIRECT STENT PLACEMENT USING A 2.75 X 20 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 9%. TARGET LESION#4 WAS A DE NOVO LESION LOCATED IN THE MID LAD WITH 70% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS TREATED DIRECT STENT PLACEMENT USING A 3.00 X 20 MM TAXUS LIBERTE STENT, WITH 9% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT EXPERIENCED EXACERBATION OF UNSTABLE ANGINA, IN-STENT RESTENOSIS OF THE TAXUS LIBERTE STUDY STENT DEPLOYED IN MID RCA. THE PATIENT WAS THEN ENROLLED IN THE ION US COA STUDY AND WAS TREATED WITH 3.0 X 32 MM ION US COA STUDY STENT JUST PROXIMAL TO THIS LESION. AFTER DILATION WITH AN APEX BALLOON THERE WAS ADVENTITIAL RUPTURE NOTED WHICH WAS TREATED WITH PLACEMENT OF 3.0 X 8 MM ION US COA STUDY STENT. IN (B)(6) 2013, THE PATIENT PRESENTED WITH BREATHLESSNESS AND NAUSEA. EMERGENCY MEDICAL SERVICE (EMS) WAS CALLED SINCE THE PATIENT SUFFERED HEMODYNAMIC COLLAPSE FOR WHICH CARDIOPULMONARY RESUSCITATION (CPR) AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED FOLLOWED BY ADMINISTRATION OF PRESSOR THERAPY, INTUBATION AND VENTILATION. SPONTANEOUS CIRCULATION WAS RESTORED. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED, CONSISTENT WITH THE PROTOCOL DEFINITION OF MI. ADMISSION ELECTROCARDIOGRAM (ECG) REVEALED SINUS BRADYCARDIA WITH ST AND T WAVE CHANGES. THE SUBJECT WAS DIAGNOSED WITH ST ELEVATION MI AND CARDIAC CATHETERIZATION WAS RECOMMENDED . AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND PRASUGREL MEDICATION WHERE THE LAST DOSAGE WAS ON APRIL 2012. THE 80%-90% DIFFUSE STENT THROMBOSIS OF THE PREVIOUSLY PLACED STUDY STENTS AND 3.5 X 20 MM TAXUS LIBERTE STENT WAS TREATED WITH BALLOON ANGIOPLASTY WITH 20% RESIDUAL STENOSIS. DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE LESION IN THE RCA WAS ATTEMPTED TO BE CROSSED WITH A CHOICE EXTRA SUPPORT WIRE WHICH WAS UNABLE TO CROSS THE LESION AS THERE WERE MULTIPLE AREAS OF HANGUPS NOTED IN THE STENTED PORTION. ADDITIONALLY, 3.5 MM X 30 MM QUANTUM BALLOON CATHETER WAS ATTEMPTED TO BE ADVANCED INTO THE STENTED REGION. HOWEVER, IT COULD NOT BE ADVANCED THROUGH THE DISTAL PORTION OF THE STENTED REGION. SUBSEQUENTLY, THIS WAS EXCHANGED WITH A 2.5 MM X 30 MM QUANTUM BALLOON CATHETER WHICH WAS USED TO DILATE THE DISTAL PORTION OF THE STENTED REGION RESULTING IN 20% RESIDUAL STENOSIS. AT 4 DAYS POST EVENT, THE PATIENT DIED AT 12:21 HRS. THE PRIMARY CAUSE OF DEATH WAS ST ELEVATION MI. DEATH CERTIFICATE IS NOT AVAILABLE. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52066 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378350 0013293585

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| R