BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3052105 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02407
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    July 6, 2012
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: 1953. PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 80 % STENOSIS. NO INDICATION FOR THE TREATMENT OF THIS 75% STENOSIS IN CONSIDERATION OF THE GOOD RESULT IN THE LAD OTHERWISE. THE NON ACCESSIBLE SEPTAL BRANCH WHICH IS NOTED IN THE PREVIOUS CORONARY ANGIOGRAM WAS TREATED WITH MAXIMUM MEDICAL TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, JAILING, SILENT ISCHEMIA AND ANGINA OCCURRED. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 65% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.2MM. THE TARGET LESION #1 WAS TREATED WITH DIRECT STENT PLACEMENT OF 3.00 MM AND 20 MM PROMUS ELEMENT STENT, WITH 5% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH SILENT ISCHEMIA AND WAS HOSPITALIZED ON THE SAME DAY. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED REVEALING LAD (TARGET VESSEL) PATENT. THERE WAS 75% OSTIAL STENOSIS IN THE SEPTAL BRANCH WHICH IS IMPRISONED IN THE STENT MESH OF THE PREVIOUSLY PLACED STUDY STENT THAT COVERS THE ORIGIN SEPTAL BRANCH AND ATHEROMATOUS DISEASE IN THE DISTAL SEPTAL BRANCH. THE PATIENT WAS DISCHARGED ONE DAY POST ANGIOGRAPHY. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. MEDICATION WAS GIVEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED NOT RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156938 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 14031122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention