BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3143401 · Received June 3, 2013

    Report

    Report Number
    2134265-2013-03594
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    February 12, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR#2134265-2013-03595, 2134265-2013-03598, AND 2134265-2013-03599. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT DIED. IN (B)(6) 2008, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 3) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 90% STENOSED, 8.0 X 2.25MM TARGET LESION WAS LOCATED IN THE 3RD OBTUSE MARGINAL BRANCH (OM). THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 12 MM STUDY STENT, WITH 0% RESIDUAL STENOSIS. IN ADDITION, A 90% NON-TARGET LESION LOCATED IN THE SAPHENOUS VEIN GRAFT TO 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF TAXUS EXPRESS 2 STENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2009, A LESION LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PLACEMENT OF TAXUS LIBERTE AND PROMUS STENTS. IN ADDITION, A LESION LOCATED IN AN UNKNOWN GRAFT TO THE 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF A PROMUS STENT. IN (B)(6) 2012, A LESION LOCATED IN PROXIMAL RCA WAS TREATED WITH PLACEMENT OF AN ION STENT. IN ADDITION, A NON-TARGET LESION LOCATED IN 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF PROMUS STENT IN (B)(6) 2013, THE PATIENT PRESENTED WITH EXTREME SHORTNESS OF BREATH AND PALPITATIONS. THE PATIENT WAS DIAGNOSED WITH "CARDIOMYOPATHY END-STAGE" AND DIED TEN DAYS LATER. CAUSE OF DEATH WAS ¿CARDIOMYOPATHY END-STAGE¿.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THE PATIENT DIED FROM END-STAGE CARDIOMYOPATHY. NOW IT IS REPORTED THAT THE PATIENT DIED FROM PROGRESSIVE SHORTNESS OF BREATH SECONDARY TO CONGESTIVE HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245214 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 11069283

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death