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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 PED2-500-30
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
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 two pipelines would not open distally. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery with a max diameter of 7mm. The landing zone was 4. 5mm on the distal side and 4mm on the proximal side. It was noted the patient's vessel tortuosity was severe. It was reported that the first device would not open distally regardless of several attempts and one recapture to adjust the ptfe sleeves. New device (same size and lot#) was opened as well as new phenom 27. Second attempt resulted in the same outcome. The device would not flower or open. Distal edge of the braid appeared frayed upon observation after removal of second device. The doctor indicated that potentially the extremely tortuous anatomy contributed to the failure of the device to open. They are considering bringing the patient back for a fred flow diversion attempt as that device may open easier in such anatomy. The pipeline was not positioned in a bend. More than 50% of the pipeline had been deployed when it failed to open. The pipeline was resheathed "less than or equal to 2 times. " there were no additional steps or other devices required to open the pipeline. There any patient symptoms or complications associated with this event.
 
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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 Key12447629
MDR Text Key270569346
Report Number2029214-2021-01141
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-30
Device Catalogue NumberPED2-500-30
Device Lot NumberB207190
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 Received09/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2021
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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