BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA SELF-EXPANDING STENT SYSTEM

    MDR report key: 5489258 · Received March 9, 2016

    Report

    Report Number
    2134265-2016-01478
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    January 13, 2016
    Report Date
    February 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS: MDR ID: 2134265-2016-01479. (B)(6). IT WAS REPORTED THAT VESSEL SPASM OCCURRED. IN (B)(6) 2014, THE PATIENT PRESENTED AS AN OUTPATIENT AND WAS TREATED WITH ANTIPLATELET THERAPY OR GIVEN A DOSE PRIOR TO THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE LEFT MID (SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS, WAS 50 MM LONG AND A REFERENCE VESSEL DIAMETER OF 5.5 MM, AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A DRUG ELUTING STENT (DES) SFA STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. A PREVIOUSLY IMPLANTED INNOVA SELF-EXPANDING STENT WAS FOUND TO HAVE 90% IN-STENT RESTENOSIS (ISR). PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO TREAT THE ISR OF THE INNOVA SELF-EXPANDING STENT. IN (B)(6) 2016, A DE NOVO STENOSIS WAS STENTED IN THE LEFT PROXIMAL SFA. SUBSEQUENTLY, A 6 X 60 INNOVA SELF-EXPANDING STENT WAS DILATED AND WHEN THE SHEATH WAS REMOVED, A SPASM OF THE SFA WAS OBSERVED AND WAS SUBSEQUENTLY DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144378 INNOVA SELF-EXPANDING STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE UNK695

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention