BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA?

    MDR report key: 3030697 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02107
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED THE THUMBWHEEL LOCK WAS POSITIONED ON THE THUMBWHEEL; HOWEVER, IT CANNOT BE DETERMINED IF THE THUMBWHEEL LOCK WAS REMOVED THEN REPLACED DURING HANDLING/USE OF THE DEVICE. THE OUTER SHAFT WAS KINKED AT THE NOSE CONE. THE STENT WAS PROTRUDING 1MM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THERE WAS NO OTHER DAMAGE. THERE WAS NO EVIDENCE OF ANY QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, PREMATURE STENT DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS PERFORMED TO 3.0MM. A 6X100X130 INNOVA STENT WAS ADVANCED , BUT WAS UNABLE TO CROSS HALF OF THE OCCLUDED LESION SUBINTIMALLY. MULTIPLE DILATIONS WERE PERFORMED, BUT THE STENT APPEARED TO BE "JAMMING" IN THE SUBINTIMAL SPACE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE DEVICE WAS REMOVED AND IT WAS NOTED THAT 2-4MM OF STENT HAD BEGUN TO DEPLOY, ALTHOUGH THE THUMBWHEEL LOCK WAS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH NON BSC STENT. THERE WERE NO 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, PREMATURE STENT DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS PERFORMED TO 3.0MM. A 6X100X130 INNOVA STENT WAS ADVANCED , BUT WAS UNABLE TO CROSS HALF OF THE OCCLUDED LESION SUBINTIMALLY. MULTIPLE DILATIONS WERE PERFORMED, BUT THE STENT APPEARED TO BE "JAMMING" IN THE SUBINTIMAL SPACE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE DEVICE WAS REMOVED AND IT WAS NOTED THAT 2-4MM OF STENT HAD BEGUN TO DEPLOY, ALTHOUGH THE THUMBWHEEL LOCK WAS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH NON BSC STENT. THERE WERE NO 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
    134008 INNOVA? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939181061030 15205163

    Patients

    Seq Age Sex Outcome Treatment
    1