BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA?

    MDR report key: 3050367 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02121
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM MALFUNCTIONED, STENT DAMAGE AND A VESSEL RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A FEMORAL ARTERY. THE 7.0MM X 150-160MM, 90% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. UTILIZING A CONTRALATERAL APPROACH, THE 7X180X130 INNOVA STENT SYSTEM WAS ADVANCED INTO THE TRUE LUMEN OF THE SFA. WHEN THE STENT WAS APPROXIMATELY 2/3 DEPLOYED, THE THUMB WHEEL ON THE DEPLOYMENT MECHANISM LOCKED UP. THE PHYSICIAN THEN NOTED SHORTENING OF THE STENT VIA ANGIOGRAPHY AS THE ¿STENT FOLDED IN ON ITSELF.¿ DEPLOYMENT OF THE STENT WAS COMPLETED WITH THE MANUAL PULL GRIP AND POST-DILATION WAS PERFORMED WITH AN UNSPECIFIED 7.0MM BALLOON. ANGIOGRAPHY REVEALED A VESSEL RUPTURE IN THE FIRST THIRD OF THE STENT, IN THE AREA WHERE THE STENT WAS FOLDED ON ITSELF, EVIDENCED BY CONTRAST EXTRAVASATION. ANOTHER UNSPECIFIED BALLOON WAS INFLATED FOR 10 MINUTES RESOLVING THE RUPTURE AND RESULTING IN TIMI III DISTAL FLOW, CONFIRMED VIA ANGIOGRAPHY. AT AN UNSPECIFIED TIME, THE PATIENT COMPLAINED OF AN ACHE IN THEIR THIGH. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT¿S STATUS IS STABLE. THE PATIENT WAS ASYMPTOMATIC WHEN DISCHARGED TO HOME. 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, THE STENT DELIVERY SYSTEM MALFUNCTIONED, STENT DAMAGE AND A VESSEL RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A FEMORAL ARTERY. THE 7.0MM X 150-160MM, 90% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. UTILIZING A CONTRALATERAL APPROACH, THE 7X180X130 INNOVA STENT SYSTEM WAS ADVANCED INTO THE TRUE LUMEN OF THE SFA. WHEN THE STENT WAS APPROXIMATELY 2/3 DEPLOYED, THE THUMB WHEEL ON THE DEPLOYMENT MECHANISM LOCKED UP. THE PHYSICIAN THEN NOTED SHORTENING OF THE STENT VIA ANGIOGRAPHY AS THE "STENT FOLDED IN ON ITSELF." DEPLOYMENT OF THE STENT WAS COMPLETED WITH THE MANUAL PULL GRIP AND POST-DILATION WAS PERFORMED WITH AN UNSPECIFIED 7.0MM BALLOON. ANGIOGRAPHY REVEALED A VESSEL RUPTURE IN THE FIRST THIRD OF THE STENT, IN THE AREA WHERE THE STENT WAS FOLDED ON ITSELF, EVIDENCED BY CONTRAST EXTRAVASATION. ANOTHER UNSPECIFIED BALLOON WAS INFLATED FOR 10 MINUTES RESOLVING THE RUPTURE AND RESULTING IN TIMI III DISTAL FLOW, CONFIRMED VIA ANGIOGRAPHY. AT AN UNSPECIFIED TIME, THE PATIENT COMPLAINED OF AN ACHE IN THEIR THIGH. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE. THE PATIENT WAS ASYMPTOMATIC WHEN DISCHARGED TO HOME. 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
    152944 INNOVA? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939181071830 15121184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention