BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2800830 · Received October 23, 2012

    Report

    Report Number
    9612164-2012-01561
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 23, 2012
    Report Date
    December 23, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (BASED ON REVIEW OF THE CINE IMAGES PROVIDED AND REVIEW OF THE RETURNED DEVICE NO ROOT CAUSE CAN BE DETERMINED).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (STENT MIGRATION). (DEVICE NOR IMAGES NOT RETURNED).

    Description of Event or Problem · 1

    DEVICE INVESTIGATION: THE STENT DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. THE DISTAL TIP HAD DETACHED FROM THE INNER POLYIMIDE SHAFT. THERE WAS RESIDUE, POSSIBLY GLUE EVIDENT ON THE INNER MEMBER IMMEDIATELY PROXIMAL TO THE DETACHMENT SITE. THE DISTAL AND PROXIMAL MARKERS WERE PRESENT ON THE INNER POLYIMIDE SHAFT. THERE WAS NO FURTHER DAMAGE EVIDENT TO THE RETURNED DEVICE. CINE IMAGE REVIEW: THE PROCEDURAL IMAGES CONFIRM THE PRESENCE OF THE TARGET LESION IN THE RIGHT ILIAC ARTERY. THE LESION IS BEING ACCESSED VIA THE CONTRALATERAL APPROACH. NO IMAGES WERE PROVIDED SHOWING THE DEPLOYMENT OF THE STENTS OR WITHDRAWAL OF THE DEVICE CATHETERS AFTER STENT DEPLOYMENTS. IMAGES CONFIRM THE DEPLOYMENT OF A STENT MORE PROXIMALLY THAN THE COMPLAINT STENT. THE POSITIONING OF THE STENT MORE DISTALLY IN THE VESSEL CAN BE SEEN FROM THE IMAGES; HOWEVER, IMAGES OF THIS STENT BEING DEPLOYED WERE NOT CAPTURED. BUT IMAGES OF THE DEPLOYED STENT SHOW THAT THE STENT POSITION POST DEPLOYMENT IS MORE DISTAL THAN THE LOCATION AT WHICH THE UNDEPLOYED DELIVERY CATHETER WAS POSITIONED PRIOR TO THE STENT DEPLOYMENT. THE DISTAL END OF THE VESSEL APPEARS TO SHOW REGIONS OF CALCIFICATION AND POSSIBLE VESSEL DISEASE. NO IMAGES WERE PROVIDED SHOWING THE DIFFICULTIES EXPERIENCED DURING THE REMOVAL OF THE DELIVERY CATHETER.

    Description of Event or Problem · 1

    THE PHYSICIAN CONFIRMED THAT THE COMPLETE SE CATHETER TIP DID NOT REMAIN IN THE PATIENT.

    Description of Event or Problem · 1

    HOLD BY MC.THE PHYSICIAN ATTEMPTED TO IMPLANT A COMPLETE SE STENT IN A LESION IN THE SFA; HOWEVER, DURING THE PROCEDURE THE STENT JUMPED FORWARD AND LOCATED IN AN AREA OTHER THAN THE TARGET LESION. THE DEVICE WAS NOT INSPECTED PRIOR TO USE.THE LESION WAS NOT PRE-DILATED PRIOR TO THE PROCEDURE. NO DIFFICULTIES ENCOUNTERED FLUSHING THE DEVICE. NO RESISTANCE ENCOUNTERED LOADING THE DEVICE ONTO THE GW, THROUGH THE VALVE, INTO THE GUIDE CATHETER OR WHEN ADVANCING THE DEVICE TO/ACROSS THE TARGET LESION. THE DEVICE PAST THROUGH THE PROXIMAL PART OF A SELF EXPANDING STENT. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE DELIVERY SYSTEM THROUGH THE ILIAC. THE PHYSICIAN IMPLANTED ANOTHER COMPLETE SE STENT IN THE TARGET LESION TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006043977

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention