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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-400-16
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that there was excessive friction observed with the flow diverter. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the a1 with a max diameter of 6mm and a 4mm neck diameter. It was noted the patient's vessel tortuosity was moderate. It was reported that there was excessive friction observed with the flow diverter, taking the flow diverter without being positioned correctly. When trying to relocate the product, it failed to sheath the device due to the aforementioned excess friction and the system ended up releasing in an unwanted position and was not complying with the desired use. The middle of the pipeline was stuck in the distal end of the catheter during delivery. The catheter was flushed continuously with a heparinized saline. The physician released the load (slack) in the system however the issue did not resolve. The catheter was not damaged and the pushwire was not damaged. The pipeline did not jump during deployment. Only 1 pipeline was used during the procedure. The tip of the catheter was not under stress and did not move during the deployment.  there were no patient symptoms or complications associated with this event. There was no medical or surgical intervention needed to prevent impairment. A dapt (dual antiplatelet treatment) was administered and the pru level was 5000. The angiographic result post procedure was normal. The pipeline was used on-label and prepared as indicated in the ifu.   ancillary devices include: avigo guidewire.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12910291
MDR Text Key286742720
Report Number2029214-2021-01546
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-16
Device Catalogue NumberPED2-400-16
Device Lot NumberB254635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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