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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 PED2-475-25
Device Problems Positioning Failure (1158); Unintended Movement (3026); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
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 the pipeline failed to open and there was difficulty during deployment. The patient was undergoing treatment for a cavernous aneurysm with a maximum diameter of 13mm. The distal vessel diameter was 4. 8mm, and the proximal vessel diameter was 4. 9mm. It was reported that when the sleeve of pipeline was removed on the middle cerebral artery the deployment was poor. However, the mic rocatheter was dropped on the internal carotid artery without any actions, and the deployment was started.  the distal end of the stent opened in the landing zone on the distal side, but the stent did not open at all beyond the tortuous part.  after that, when wire pushing and resheathing were performed several times to open the stent, it was confirmed that the tip coil of pipeline did not move even when the wire was pushed and pulled, and the behavior seemed to deviate from the wire.  before the tip coil distally migrated, slowly cover the tip coil with phenom 27, and removed the device together with the phenom27 without any actions. The phenom 27 and pipeline were replaced.  the event was said to be not associated with a patient.  the devices were prepared and hydrated according to the instructions for use (ifu). Ancillary devices include a launcher 8fr guide catheter, phenom 27 microcatheter, and chikai 14 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11770090
MDR Text Key249266597
Report Number2029214-2021-00531
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-25
Device Catalogue NumberPED2-475-25
Device Lot NumberB049757
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2020
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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