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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COMPLETE SE ILIAC; STENT, ILIAC
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MEDTRONIC COMPLETE SE ILIAC; STENT, ILIAC Back to Search Results
Model Number 00613994726803
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2016
Event Type  Injury  
Event Description
(b)(6) underwent a percutaneous transluminal angioplasty and stent placement of right femoral popliteal artery with dr (b)(6).Upon removal of the stent delivery device, it was noted that approximately a 1.25 cm portion of the tip of that delivery device was not attached to the unit.Fluoroscopic evaluation revealed the tip of this device to be on the guidewire in place with the location of the foreign body in the upper third of the thigh area.Dr (b)(6) attempted to use a snare device over the wire through the sheath to remove this foreign body but was unsuccessful.Because the pt's tibioperoneal trunk is chronically occluded he used a catheter to advance this small foreign body segment to the distal tibioperoneal trunk level and left it in place.
 
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Brand Name
COMPLETE SE ILIAC
Type of Device
STENT, ILIAC
Manufacturer (Section D)
MEDTRONIC
minneapolis MN
MDR Report Key5573258
MDR Text Key42690192
Report NumberMW5061635
Device Sequence Number1
Product Code NIO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2018
Device Model Number00613994726803
Device Catalogue NumberSC660LV
Device Lot Number0007920415
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/08/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age85 YR
Patient Weight64
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