BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA¿

    MDR report key: 5442339 · Received February 17, 2016

    Report

    Report Number
    2134265-2016-00668
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    December 10, 2015
    Report Date
    January 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MDR ID# 2134265-2016-00669. (B)(6). IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT'S RUTHERFORD ASSESSMENT WAS CATEGORY 3 AND WAS SUBSEQUENTLY TREATED. THE TARGET LESION WAS LOCATED IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY (PPA) WITH 100% STENOSIS AND WAS 140MM LONG WITH A REFERENCE VESSEL DIAMETER OF 5MM AND WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A TWO INNOVA STENTS, SIZED 6 X 79 X 130 AND 6 X 150 X 130 IN OVERLAPPING MANNER. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS TREATED AS AN OUTPATIENT. IN (B)(6) 2015, DUPLEX SCAN REVEALED ISR IN THE RIGHT SFA. TWELVE DAYS LATER, THE PATIENT RETURNED FOR A PLANED ANGIOGRAM AND THE 80% RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN RIGHT MID TO DISTAL SFA WAS TREATED WITH LASER ATHERECTOMY FOLLOWED BY DRUG COATED BALLOON ANGIOPLASTY. POST TREATMENT, RESIDUAL STENOSIS WAS 10%. 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
    97602 INNOVA¿ STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939176068030 15122726

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention