BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 5002938 · Received August 14, 2015

    Report

    Report Number
    9612164-2015-01395
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 16, 2015
    Report Date
    September 21, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED WITH THE STENT NOT PRESENT ON THE DELIVERY SYSTEM. NO FURTHER DAMAGE WAS NOTED TO THE DEVICE. CORRECTION: FRACTURED PART OF THE STENT WAS DEPLOYED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PHYSICIAN STATED THAT THEY THOUGHT THAT THE STENT DELIVERY SYSTEM WAS PARTIALLY INSIDE THE SHEATH AND THIS IS WHAT CAUSED THE STENT NOT TO COME OFF OF THE DELIVERY SYSTEM AND THEN GET STRETCHED INTO THE ILIAC VESSELS, ALL THE WAY TO THE AORTIC ILIAC BIFURCATION. NO FRACTURED PART OF STENT WAS DEPLOYED. IT WAS LEFT THERE WITHOUT COMPLICATION. PHYSICIAN WAS INITIALLY TREATING THE SFA AND STRETCHED THE STENT BACK INTO THE ILIAC ALL THE WAY TO THE AORTIC ILIAC BIFURCATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PHYSICIAN USED A COMPLETE SE STENT DEVICE TO TREAT A CHRONIC TOTAL OCCLUSION PROXIMAL / MID LEFT SFA LESION WITH A LITTLE TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU, INSPECTED AND PREPPED WITHOUT ANY ISSUES NOTED. DURING DELIVER THE STENT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THE STENT DEFORMATION AND FRACTURE WAS OBSERVED POST STENT DEPLOYMENT; THE STENT WAS STRETCHED DURING DEPLOYMENT EITHER DUE TO ACCESS SHEATH OR A STENT CATHETER ISSUE. ADDITIONALLY THE STENT DISLODGED. IT WAS REPORTED THAT THE STENT WAS STRETCHED WHEN CATHETER REMOVAL WAS ATTEMPTED. STENT FRACTURED AND SOME WAS LEFT IN PATIENT DEPLOYED. THE PHYSICIAN STATED THAT THE STENT MAY HAVE DEPLOYED PARTIALLY WITHIN THE ACCESS SHEATH OR THE STENT DELIVERY SYSTEM HELD ONTO THE STENT AND STRETCHED AND FRACTURED THE STENT. THE PHYSICIAN EXPERIENCED DIFFICULTIES REMOVING THE DEVICE POST STENT DEPLOYMENT. THE STENT WAS DEPLOYED IN AN UNINTENDED LESION SITE; A PORTION OF THE FRACTURED STENT WAS ACCIDENTALLY DEPLOYED IN THE PATIENT'S ILIAC ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538550 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0007579502

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR