BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA?

    MDR report key: 4192560 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06350
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: SPRING 2014. (B)(4). 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, SHAFT DETACHMENT WAS NOTED. IN (B)(6) 2013, THE PATIENT UNDERWENT STENTING OF THEIR SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) CLASSIFIED AS FONTAINE STAGE 4. IT WAS A LONG SFA OCCLUSION, LONGER THAN THE STENT SELECTED. A 7X200X75MM INNOVA BARE METAL STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT, THE THUMBWHEEL OF THE DELIVERY SYSTEM MADE A STRANGE SOUND AND STOPPED WORKING. PULLING THE PULL GRIP WAS NOT WORKING EITHER, THEREFORE, THE REST OF THE STENT WAS DEPLOYED BY PULLING BACK THE DELIVERY SYSTEM. AFTER DEPLOYING THE STENT IN THAT WAY, SOME ELONGATING OF THE STENT WAS NOTED. THE CONTROL X-RAYS SHOWED ACCEPTABLE POSITIONING OF THE STENT IN THE SFA. AFTER POST-DILATION WITH A 7MM - 8CM WANDA PTA BALLOON, THE X-RAYS SHOWED A PATENT SFA WITH A VERY NICE LUMEN. IN THE SPRING OF 2014, THE PATIENT HAD THE FEELING THAT THERE WAS SOMETHING IN THE PROXIMAL PART OF HER CALF. ULTRASOUND SHOWED A FOREIGN BODY, WHICH WAS REMOVED BY SURGERY IN (B)(6) 2014 AND GIVEN TO THE PATIENT. A PICTURE OF THE REMOVED FOREIGN BODY WAS PROVIDED TO THE PHYSICIAN AND APPEARS TO BE A PORTION OF THE SHAFT OF THE INNOVA STENT DELIVERY SYSTEM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. 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
    672882 INNOVA? STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939180072070 0015316361

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7MM - 8CM WANDA PTA BALLOON