BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1695540 · Received May 21, 2010

    Report

    Report Number
    2134265-2010-02361
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B) (4). 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)

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM CORRECTED THAT A 2.50 X 20 MM TAXUS LIBERTE STENT WAS IMPLANTED NOT A 2.75X20MM, AND ADDITIONAL INFORMATION ADDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ONE DAY POST PROCEDURE, THE PATIENT'S COURSE WAS COMPLICATED WITH HEMATURIA. THIS WAS NOTED AFTER A URINARY CATHETERIZATION. THE PATIENT WAS TREATED WITH BLADDER IRRIGATION. FOUR DAYS LATER, GUSTO BLEEDING CLASSIFICATION WAS SEVERE. THE PATIENT WAS TREATED WITH INTRAVENOUS INOTROPIC AGENTS FOR HYPOTENSION. AN EMERGENCY LEFT THORACOTOMY WAS PERFORMED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE NEXT DAY HE BECAME HYPOTENSIVE REQUIRING DOPAMINE. A TRANSTHORACIC ECHO REVEALED A CONTAINED FREE RUPTURE OF HIS INFERIOR LATERAL FREE WALL. THE PATIENT WAS TRANSFERRED TO AN OUTSIDE FACILITY. AFTER ARRIVAL, HE DEVELOPED VENTRICULAR FIBRILLATION AND CARDIAC ARREST. HE UNDERWENT CARDIAC DEFIBRILLATION WITH RETURN OF PERFUSING RHYTHM. HE THEN BECAME BRADYCARDIC AND ENTERED PEA ARREST. RESUSCITATIVE MEASURES WERE INITIATED AND THE PATIENT ONCE AGAIN HAD RESTORATION OF PERFUSING RHYTHM. HE WAS INTUBATED. AN EMERGENT TRANSTHORACIC ECHO AND TRANSESOPHAGEAL ECHO REVEALED POSTEROLATERAL FREE WALL RUPTURE WITH HEMOPERICARDIUM AND SURROUNDING THROMBUS COMPRESSING THE LEFT VENTRICLE. A CARDIAC SURGERY CONSULTATION WAS REQUESTED FOR EVALUATION OF OPERATIVE INTERVENTION. THE PATIENT'S CRITICAL PROGNOSIS WAS DISCUSSED WITH THE FAMILY. THE FAMILY ELECTED TO PROCEED WITH OPERATIVE INTERVENTION TO REPAIR THE LEFT VENTRICULAR RUPTURE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND BECAME PROGRESSIVELY HYPOTENSIVE REQUIRING INTERMITTENT BOLUSES OF EPINEPHRINE. AT THE TIME OF OPENING HIS CHEST, THE PATIENT HAD MINIMAL CARDIAC ACTIVITY. AN EMERGENCY THORACOTOMY WAS PERFORMED. THE AREA OF RUPTURE WAS SEEN AND OPEN CARDIAC MASSAGE WAS PERFORMED. INTRACARDIAC EPINEPHRINE WAS GIVEN AND MASSAGE CONTINUED. NO PROGRESS WAS MADE IN REINITIATING CARDIAC ACTIVITY AND THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS VENTRICULAR RUPTURE. NO AUTOPSY WAS PERFORMED AND NO DEATH CERTIFICATE WAS OBTAINED.

    Description of Event or Problem · 1

    (B) (4). SAME CASE AS 2134265-2010-02360 AND 2134265-2010-02362 IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND EXPIRED. LESION #1 WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 75% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.25 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.00 MM X 12 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION #2 WAS A BIFURCATED LESION LOCATED IN THE 1ST OBTUSE MARGINAL (1ST OB MARG) WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.75 X 20 MM TAXUS LIBERTE STENT WITH RESIDUAL STENOSIS OF 0%. A GRADE A DISSECTION OCCURRED WITHIN THE TARGET LESION. NO DISSECTION INTERVENTION WAS REQUIRED. THE NEXT DAY AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A MI. 3 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A STENT THROMBOSIS (ST). THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB HAVING CHEST PAIN WITH MARKED ST ELEVATION IN THE INFEROLATERAL LEADS. CINEANGIOGRAMS SHOWED THE STENT IN THE DISTAL LEFT MAIN WAS PATENT. THERE WAS A 100% OCCLUSION WITH IN-STENT THROMBUS IN THE STENT IN THE OM. STENT THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY. THE PATIENT WAS DIAGNOSED WITH A SECOND MYOCARDIAL RE-INFARCTION. THE PATIENT WAS TREATED WITH ANGIOPLASTY TO THE OCCLUDED STENT AND PLACEMENT OF A 2.5MM TAXUS LIBERTE STENT IN THE PROXIMAL OM BRANCH. RESIDUAL STENOSIS WAS 0%. THERE WAS MILD DISSECTION PROXIMAL TO THE PREVIOUSLY PLACED STENT. THE PATIENT EXPERIENCED PERSISTENT CHEST PAIN WITH ST ELEVATION. INTRA-AORTIC BALLOON PUMP WAS INTRODUCED. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE LAB IN STABLE CONDITION. THE NEXT DAY, THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND LEFT VENTRICULAR RUPTURE RESULTING IN PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND SUCCESSFULLY IMPLANTING A 2.50 X 20 MM TAXUS LIBERTE STENT NOT A 2.75X20MM STENT AS INITIALLY REPORTED. PRIOR TO STENT DEPLOYMENT, MULTIPLE DILATATIONS WERE PERFORMED IN THE OBTUSE MARGINAL WHICH RESULTED IN A TRANSIENT TOTAL OCCLUSION OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612300 12925161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R