BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX¿

    MDR report key: 3042146 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02044
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. (B)(6) 2013 - THE PATIENT PRESENTED WITH STABLE ANGINA. TWO TARGET LESIONS WERE TREATED DURING THE PROCEDURE. THE FIRST TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS, A LENGTH OF 12 MM, AND REFERENCE VESSEL DIAMETER OF 4 MM. WHICH WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X 12 MM (B)(4) STENT. POST DILATION WAS PERFORMED WITH A 4.0 X 8 MM APEX BALLOON. REPEAT ANGIOGRAPHY FOLLOWING POSTDILATATION REVEALED A DISTAL EDGE DISSECTION WHICH WAS TREATED WITH THE PLACEMENT OF A SECOND 4.0 X 12 MM EVOLVE II STUDY STENT, RESIDUAL STENOSIS WAS 0%. THE SECOND TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH 95% STENOSIS, A LENGTH OF 15 MM, AND REFERENCE VESSEL DIAMETER OF 3 MM. WHICH WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM (B)(4) STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145466 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895908400 14423444

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention