BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3202955 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04612
    Event Type
    Death
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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). SAME CASE AS MDR ID: 2134265-2013-04611; 2134265-2013-04610. IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 2 TARGET LESIONS. FIRST LESION WAS LOCATED IN THE AC MARGINAL WITH 90% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED BARE-METAL STENT AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.3 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 24 MM PRMOUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. THE SECOND LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 70% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED BARE-METAL STENT AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 X 24 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE NEXT DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE SUBJECT EXPERIENCED NON ST ELEVATION MYOCARDIAL INFARCTION AND UPPER GASTROINTESTINAL BLEEDING. ON THE NIGHT OF (B)(6) 2013, THE SUBJECT DEVELOPED CHEST PRESSURE OF UNKNOWN ETIOLOGY WHICH WAS ASSOCIATED WITH INCREASED DYSPNEA AND PERSISTED THROUGH THE NIGHT. THE NEXT MORNING, WHILE EN ROUTE TO THE HOSPITAL, THE SUBJECT BECAME INCREASINGLY HYPOXIC, TACHYCARDIC AND UNRESPONSIVE, REQUIRING INTUBATION. THE SUBJECT UNDERWENT ECG WHICH INDICATE A 1ST DEGREE AV BLOCK WITH PVC'S AND PROLONGED QT/QTC INTERVALS. ON ARRIVAL TO THE HOSPITAL, THE SUBJECT APPEARED TO HAVE EPISODES OF GENERALIZED CLONIC MOVEMENTS AND AN IMPRESSIONS OF STATUS EPILEPTICUS AND ANOXIC BRAIN INJURY WERE DRAWN. THE FOLLOWING DAY, THE SUBJECT WAS REFERRED TO HOSPICE CARE AND DNR ORDER WAS INITIATED AND THE SUBJECT WAS FOUND TO BE UNRESPONSIVE AND WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS ASSESSED AS ANOXIC ENCEPHALOPATHY SECONDARY TO RESPIRATORY/CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302915 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death