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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 PED2-500-14
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline shield that failed to open at the distal end and then was observed to be damaged. The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of the left internal carotid artery (l-ica). Vessel tortuosity was moderate. It was reported that the pipeline device and all accessory devices were prepared as indicated in the instructions for use (ifu). The distal end of the pipeline failed to open. The device was resheathed to get the ptfe sleeves to an "m" shape and the device then opened when deploying against. However, the braid appeared frayed and opened in a "c" shape. It was noted that the pipeline was not positioned in a vessel bend. More than 50% of the pipeline was deployed when the initial failure to open occurred. The device was resheathed 2 or less times. No other steps or devices were required to open the pipeline. The pipeline was resheathed and removed from the patient with the microcatheter. Another pipeline was then successfully implanted. There was no harm or injury to the patient. Post-procedure angiographic results showed the procedure was successfully completed with the second pipeline.
 
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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 Key12000188
MDR Text Key256244121
Report Number2029214-2021-00734
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-14
Device Catalogue NumberPED2-500-14
Device Lot NumberB180094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
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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