BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA SELF-EXPANDING STENT SYSTEM

    MDR report key: 3013406 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01755
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION RANGED FROM 12-18CM X 5-6MM. UTILIZING AN ANTEGRADE APPROACH, PRE-DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON. AN UNKNOWN SIZE INNOVA STENT WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, THE PHYSICIAN OBSERVED THE PROXIMAL RO MARKER OF THE STENT CONTINUOUSLY MOVING "DOWN" ON THE ANGIOGRAPHY IMAGE, INDICATING SHORTENING OF THE STENT, RANGING FROM 2-4CM. POST-DILATION WAS NOT PERFORMED. THE STENT WAS CONSIDERED WELL POSITIONED AND WELL APPOSED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116747 INNOVA SELF-EXPANDING STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK695

    Patients

    Seq Age Sex Outcome Treatment
    1