BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA¿

    MDR report key: 5574793 · Received April 13, 2016

    Report

    Report Number
    2134265-2016-02982
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    October 30, 2015
    Report Date
    March 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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)(6) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT'S RUTHERFORD ASSESSMENT WAS CATEGORY 3 AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INCLUDING PROXIMAL POPLITEAL ARTERY (PPA) WITH 100% STENOSIS, REFERENCE VESSEL DIAMETER OF 5.1MM, A LENGTH OF 100MM, AND WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 6X119X130 INNOVA STENT AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ANTIPLATELET THERAPY. IN (B)(6) 2015, RESTENOSIS OF THE LEFT PROXIMAL SFA AND RESTENOSIS OF THE STENT PREVIOUSLY PLACED IN DISTAL SFA WAS NOTED. IN (B)(6) 2016, 90% RESTENOSIS OF THE STUDY STENT LOCATED IN THE LEFT DISTAL SFA INCLUDING PPA AND RESTENOSIS IN THE LEFT PROXIMAL SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH 10% RESIDUAL STENOSIS. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229462 INNOVA¿ STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939176061230 15078969

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention