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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 Difficult or Delayed Activation (2577); 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
Physician information was not reported due to region privacy laws. This original information in this report has been previously reported under regulatory report # 2029214-2021-00531 but later it was discovered the events were duplicated. All further information regarding this event will be reported under this regulatory report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that after failed deployment of one pipeline, the second pipeline also failed to open and there was diff iculty 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). Additional information received regarding the second pipeline reported the pipeline was positioned in a vessel bend. This pipeline was also resheathed at least 15 times. There was no friction felt at the time of the delivery. At the time of positioning, the tip was unfolded, an anchor was applied, and the stent was not opened in the middle at the point where it exceeded the flexion. During deployment, the tip of the catheter was controlled to be in the center of the blood vessel.
 
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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 Key11924731
MDR Text Key254026780
Report Number2029214-2021-00651
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
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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