BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA VASCULAR

    MDR report key: 10020907 · Received May 4, 2020

    Report

    Report Number
    2134265-2020-05930
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 16, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIP
    UDI-DI
    08714729873990
    PMA / PMN Number
    P140028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER. RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT SYSTEM. THE OUTER SHEATH, TIP, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION REVEALED DAMAGE TO THE SHEATH 82CM FROM THE NOSECONE. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THE STENT IS OUTSIDE OF THE DEVICE. THE THUMBWHEEL LOCK IS MISSING AND THE RACK HAS MOVED 6MM FROM THE MANUFACTURED POSITION. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS FOUND DAMAGES TO THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE PREMATURE DEPLOYMENT AND RESISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE SUBCLAVIAN VEIN (SCV). PRE-DILATION WAS PERFORMED RESULTING IN A LESS THAN 50% STENOSED LESION. A NON-BSC GUIDEWIRE AND 6 FR ACCESS SHEATH WERE USED AND THE DEVICE WAS DELIVERED VIA ANTEGRADE APPROACH. IT WAS REPORTED THAT IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE LESION, THE WIRE DID NOT HAVE SMOOTH MOVEMENT. DESPITE LUBRICATING THE DEVICE THE STENT DEPLOYED APPROXIMATELY TWO STRUTS DESPITE THE SAFETY LOCK REMAINING ON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE SUBCLAVIAN VEIN (SCV). PRE-DILATION WAS PERFORMED RESULTING IN A LESS THAN 50% STENOSED LESION. A NON-BSC GUIDEWIRE AND 6 FR ACCESS SHEATH WERE USED AND THE DEVICE WAS DELIVERED VIA ANTEGRADE APPROACH. IT WAS REPORTED THAT IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE LESION, THE WIRE DID NOT HAVE SMOOTH MOVEMENT. DESPITE LUBRICATING THE DEVICE THE STENT DEPLOYED APPROXIMATELY TWO STRUTS DESPITE THE SAFETY LOCK REMAINING ON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485142 INNOVA VASCULAR STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC CORPORATION 26924 0022047193 08714729873990

    Patients

    Seq Age Sex Outcome Treatment
    1 RADIFOCUS 35 30CM| RADIFOCUS 35 30CM