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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 PED2-400-18
Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
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 were deployment issues with the pipeline.   the patient was undergoing surgery for treatment of a blister, unruptured aneurysm in the left middle cerebral artery near m2 segment with a max diameter of 1mm and a 1mm neck diameter. The landing zone was 3. 6mm on the distal side and 3. 8mm on the proximal side. It was noted the patient's vessel tortuosity was moderate. Angiographic result post procedure showed that flow rate in the aneurysm was reduced.   it was reported that the device was parked distal to the aneurysm and attempt was made to deploy the device. Device failed to take wall opposition. Device was re sheath and another attempt was taken. In 2nd attempt resistance was observed in the catheter and device got kinked. There was catheter kickback/friction during delivery. The pipeline did not jump during deployment. The pipeline was not used for an indication that is not approved (off-label). The pipeline and any accessory devices were prepared as indicated in the ifu.
 
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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 Key12961330
MDR Text Key286444240
Report Number2029214-2021-01579
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 03/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-18
Device Catalogue NumberPED2-400-18
Device Lot NumberB253077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2021
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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