BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3201725 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04405
    Event Type
    Death
    Date Received
    July 2, 2013
    Date of Event
    January 22, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). EVENT DATE: (B)(6) 2012. DEVICE IS 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 MOST PROBABLE 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA: UPDATED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. SAME CASE AS MDR#2134265-2013-00593 AND 2134265-2013-00596. . IN (B)(6) 2012, AN ION STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) AND ANOTHER ION STENT WAS IMPLANTED IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST PAIN AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SELECTIVE CORONARY ANGIOGRAPHY REVEALED 90% IN-STENT RESTENOSIS (ISR) IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 80% ISR IN THE MID AND DISTAL RIGHT CORONARY ARTERY (RCA. THE 90% ISR IN THE PROXIMAL LAD WAS TREATED WITH PLACEMENT OF A 3.00 X 18MM NON-BSC STENT. THE 80% ISR IN THE MID AND DISTAL RCA WAS TREATED WITH PLACEMENT OF A 3.25 X 18MM NON-BSC STENT AND A 3.00X 15MM NON-BSC DRUG ELUTING STENT. THREE DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED. IN (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE CHEST PAIN RADIATING TO ARM ASSOCIATED WITH DIAPHORESIS, NAUSEA AND VOMITING AND WAS HOSPITALIZED ON THE SAME DAY. AN ADMISSION ELECTROCARDIOGRAPH (ECG) REVEALED ST ELEVATION IN ANTERIOR AND INFERIOR LEADS WITH SEVERE HYPOTENSION AND BRADYCARDIA CONSISTENT WITH CARDIOGENIC SHOCK. THE PATIENT WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION. DURING THE SAME HOSPITALIZATION THE PATIENT WAS ALSO DIAGNOSED WITH RESPIRATORY FAILURE AND WAS INTUBATED FOR THE SAME. POST INTUBATION O2 SATURATION WAS 75%. THE 100% TOTAL OCCLUSION OF THE STUDY STENT IN THE LAD WAS TREATED WITH BALLOON ANGIOPLASTY WITH 80% RESIDUAL STENOSIS. IN ADDITION A NON-TARGET LESION LOCATED IN PROXIMAL AND MID RCA WAS TREATED WITH THROMBECTOMY WITH 40% RESIDUAL STENOSIS. THE PATIENT DIED OF CARDIAC CHEST PAIN THE SAME DAY. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PER DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS CARDIAC ARREST AND THAT OTHER UNDERLYING CAUSES CONTRIBUTING TO THE PATIENT'S DEATH INCLUDED CARDIAC STENT THROMBOSIS, CORONARY HEART DISEASE AND HYPERLIPIDEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302403 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death