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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 (NOW COVIDIEN-MEDTRONICS) / MEDTRONIC INC, -SWINNEA PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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EV3 (NOW COVIDIEN-MEDTRONICS) / MEDTRONIC INC, -SWINNEA PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77425-12
Device Problem Insufficient Information (3190)
Patient Problems Aneurysm (1708); Stroke/CVA (1770); Headache (1880); Occlusion (1984); Implant Pain (4561)
Event Date 04/04/2021
Event Type  Injury  
Event Description
I had surgery for a superior hypophyseal brain aneurysm on (b)(6) 2012 at (b)(6) hospital in (b)(6). They treated my aneurysm with the ev3 (now covidien-medtronics) pipeline embolization device stent (ped). I was released the next day after 1 night in the hospital with no complications. Within 2 to 3 weeks after surgery i began having excruciating head pain on the right side of my head where the stent was placed. Numerous calls to the surgeon's office resulted in them telling me that was a normal side effect after surgery. In (b)(6) 2012, i sought treatment from my primary care physician and he ordered an mri and an angiogram. The mri revealed many areas of t2 and flair signal in the right cerebrum which were classified as strokes. I was told there was not much that could be done at that point in time. I didn't receive much follow up other than the angiograms every couple of years, which came back as normal. Those tests showed that the stent was in place and my aneurysm was occluded. In (b)(6) 2020 i decided to seek treatment from a neurologist for migraine headaches. The doctor ordered mris with and without contrast. The results showed active brain lesions which were previously thought to be stroke areas back in 2012. All autoimmune and other diseases were ruled out-i had a spinal tap and ct scans. Upon consulting with her neurology team and surgeons, my doctor determined that my still active lesions (8 years later) were most likely due to foreign object damage from my surgery, possibly material flaking from the stent or catheter during my procedure. I am still under the care of this neurology team and continue to be scanned every 6 months to 12 months to monitor for changes in the lesions. Fda safety report id # (b)(4).
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
EV3 (NOW COVIDIEN-MEDTRONICS) / MEDTRONIC INC, -SWINNEA
MDR Report Key11378008
MDR Text Key233812477
Report NumberMW5099621
Device Sequence Number1
Product Code OUT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFA-77425-12
Device Lot NumberAU11-030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
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