BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 4102973 · Received September 19, 2014

    Report

    Report Number
    2134265-2014-05779
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 1, 2014
    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 A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: 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 CASE AS MDR ID# 2134265-2014-06441 AND 2134265-2014-06442. IT WAS FURTHER REPORTED THAT IN (B)(6) 2014, POST PROCEDURE, THE PATIENT DEVELOPED CARDIOGENIC SHOCK WHICH WAS TREATED MEDICALLY. ALL EVENTS WERE CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-05778, 2134265-2014-05780, 2134265-2014-05785, 2134265-2014-05786, 2134265-2014-05787, 2134265-2014-05788, 2134265-2014-05789, 2134265-2014-05790. (B)(4). IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND PATIENT WAS DIAGNOSED WITH NON- ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) ASSOCIATED WITH CARDIOGENIC SHOCK. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO OSTIAL LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 100% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 12 MM TAXUS® LIBERTÉ® STENT. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 100 % STENOSIS AND WAS 36 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. AFTER AN UNSPECIFIED SIZE CHOICE PT GUIDEWIRE CROSSED THE LESION, A 3.00MM X 20 MM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. POST BALLOON ANGIOPLASTY, CONTINUOUS RE-ACCUMULATION OF THROMBUS AND POSSIBLE DISSECTION WERE NOTED. THE PATIENT THEN DEVELOPED CARDIOGENIC SHOCK AND COMPLAINED OF SEVERE CHEST PAIN. THE LCX WAS TREATED WITH 2.75 X 38 MM TAXUS® LIBERTÉ® LONG STENT. HOWEVER, THERE WAS SOME MILD HAZINESS NOTED WHICH CONTINUED TO PERSIST. HENCE, THE LCX AND OM1 WERE DILATED WITH KISSING BALLOON TECHNIQUE USING A 2.5 MM APEX BALLOON AT 12 ATMS AND A 2.50 X 12 MM TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM WAS PLACED IN THE OSTIUM OF OM1. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN ADDITION, A NON-TARGET LESION LOCATED IN PROXIMAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY. MILD HAZINESS WAS TREATED WITH PLACEMENT OF A 3.00 X 12 MM PROMUS DRUG ELUTING STENT. THREE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2012, THE PATIENT PRESENTED WITH NSTEMI AND A 2.5 X 24 MM PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED IN DISTAL LCX. TWENTY MINUTES POST TARGET VESSEL REVASCULARIZATION (TVR), THE PATIENT HAD SIGNIFICANT ST ELEVATION AND REPEAT ANGIOGRAPHY REVEALED TOTAL OCCLUSION IN LCX. THE DISTAL LEFT CX WAS TREATED WITH BALLOON ANGIOPLASTY USING A 3.5X40MM APEX BALLOON AND PLACEMENT OF A 2.5X24MMPROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. TWO DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND PRASUGREL. ON (B)(6) 2014, THE PATIENT WAS PRESENTED WITH COMPLAINTS OF SUDDEN ONSET OF CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATION IN INFERIOR AND LATERAL LEADS AND NONSPECIFIC INTRAVENTRICULAR BLOCK. THE PATIENT WAS THEN DIAGNOSED WITH ACUTE Q-WAVE INFEROLATERAL WALL STEMI AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL AND THE STUDY DRUG PROTOCOL WAS LAST TAKEN ON (B)(6) 2012. CORONARY ANGIOGRAPHY WAS REVEALED ACUTE THROMBOTIC OCCLUSION IN OM1 OF THE 2.75 X 12 MM TAXUS® LIBERTÉ® STENT AND 2.50 X 12 MM NON-STUDY TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM; AND ACUTE THROMBOTIC OCCLUSION OF THE 2.75 X 38 MM TAXUS® LIBERTÉ® STENT AND TWO (2.5 X 24 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM) STENTS IMPLANTED IN (B)(6 2012 IN DISTAL LEFT CIRCUMFLEX (LCX).THE 100% STENOSIS IN OBTUSE MARGINAL (OM1) WAS TREATED WITH THROMBECTOMY FOLLOWING WHICH BALLOON INFLATIONS WERE DONE USING A 2.50 X 20 MM EMERGE BALLOON CATHETER. A 3.5 RUNWAY GUIDE CATHETER AND A CHOICE GUIDEWIRE WERE PASSED INTO OM1, SUBSEQUENTLY RE-THROMBOSIS OF OM1 WAS NOTED AND WAS EVENTUALLY TREATED WITH THROMBECTOMY RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION, THE OSTIUM OF THE OM2 WAS SEEN TO BE HAZY WITH 100% STENOSIS IN OM2 WHICH WAS TREATED WITH BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. THE 90% STENOSIS IN DISTAL LCX WAS ALSO TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75 X 24 MM PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM, HOWEVER FOLLOWING DEPLOYMENT,SPASM O THROMBUS IN OM3 WAS NOTED. THE 100% STENOSIS IN OM3 ALONG WITH SPASM/THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE THE RE-OCCLUSION OF THE CIRCUMFLEX OM SYSTEM WAS NOTED WHICH WAS TREATED WITH ASPIRATION THROMBECTOMY. THE 90% STENOSIS IN DISTAL LCX EXTENDING UP TO OM2 WAS TREATED WITH KISSING BALLOON ANGIOPLASTY AND PLACEMENT OF TWO 2.5 X 16 MM DRUG ELUTING PROMUS PREMIER STENTS WHICH WERE DEPLOYED IN A KISSING TECHNIQUE FROM THE MID TO DISTAL CIRCUMFLEX AND OM2.IN ADDITION MILD HAZINESS WAS NOTED BEYOND OM2. THE 90% STENOSIS, WITH HAZINESS, IN DISTAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.25 X 12 MM PROMUS STENT AND THE 90% STENOSIS IN PROXIMAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%.THREE DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND BRILINTA WITH RECOMMENDATION OF FOLLOW UP AFTER ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584300 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638270 13583217

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R