BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 2920593 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00058
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    April 25, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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: 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 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

    (B)(4). SAME PATIENT AS MDR #2134265-2013-00424. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED FOR ANEMIA 2 DAYS AFTER THE PROCEDURE. FIVE DAYS AFTER INITIAL PROCEDURE, A SECOND LESION WAS TREATED. IT WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY AND WAS DESCRIBED AS 16MM LONG, WITH A VESSEL DIAMETER OF 2.25MM AND 95% STENOSIS. AFTER PREDILATION A 2.25X16MM TAXUS ELEMENT STENT WAS IMPLANTED WITH 0% RESIDUAL STENOSIS. .

    Description of Event or Problem · 1

    SAME PATIENT AS MDR#2134265-2013-00424. (B)(4) TRIAL. IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION MYOCARDIAL INFARCTION (MI) OCCURRED. THE PATIENT PRESENTED DUE TO SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS DESCRIBED AS 22MM LONG, WITH A VESSEL DIAMETER OF 2.5 MM AND 85% STENOSIS. THE LESION WAS TREATED WITH IMPLANTATION OF A 2.50 MM X 24 MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PROGRESSIVE INCREASED DYSPNEA, CRUSHING CHEST PAIN RADIATING TOWARDS THE BACK AND INCREASING RIGHT FOOT PAIN. HE WAS HOSPITALIZED ON THE SAME DAY. ELEVATED TROPONIN VALUE WAS OBSERVED AND MI WAS REPORTED. ECG WAS PERFORMED AND THE SUBJECT EXPERIENCED ISCHEMIC SYMPTOMS. ADDITIONALLY RIGHT LOWER LIMB SUPER INFECTION WAS SUSPECTED AND THE PATIENT WAS REFERRED TO THE VASCULAR SURGERY DEPARTMENT. IT WAS DIAGNOSED AS GRADE IV CHRONIC ARTERIAL INSUFFICIENCY WITH SUPER INFECTION. HE WAS SHIFTED TO THE INTERNAL MEDICINE DEPARTEMENT. THE PATIENT WAS ALSO DIAGNOSED WITH ANOTHER EPISODE OF MULTI-FACTORIAL ANEMIA. MEDICATION WAS GIVEN TO TREAT THE MI AND SEPSIS. THE EVENT WAS CONSIDERED NOT RESOLVED. FIVE DAYS LATER THE PATIENT EXPIRED. THE CAUSE OF THE DEATH WAS "SEPSIS." THE INVESTIGATOR ASSESSED THE DEATH EVENT AS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    PREVIOUSLY IT WAS REPORTED THAT THE PATIENT DIED IN (B)(6) 2012, NOW IT IS REPORTED THAT THE PATIENT DIED IN (B)(6) 2012. CLINICAL ASSESSMENT INCLUDES MULTIPLE PATHOLOGIES, POSTOPERATIVE FOR BELOW KNEE AMPUTATION OF LEFT LOWER LIMB, ACUTE KIDNEY INJURY, CONTINUOUS RENAL FILTRATION, ACUTE RESPIRATORY FAILURE, NON-INVASIVE VENTILATION, ISCHEMIA OF SMALL INTESTINE AND EXITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25542 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524250

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention