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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-16
Device Problems Break (1069); Unintended Ejection (1234); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
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 two pipelines failed to open distally, and one detached in the microcatheter. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ica. The patient's vessel tortuosity was mo derate. The landing zone was 5mm distal and 5mm proximal. It was reported that the first pipeline would not open distally. When the physician tried to take the first pipeline out and pull it back into microcatheter, the stent detached from the wire inside the microcatheter. The physician tried to deploy a second device and again it would not open distally. That device was removed without incident and the case was aborted. The distal part of the pipelines had been positioned in a bend, and less than 50% of the devices had been deployed at the time. The physician had resheathed the pipelines more than 2 times. No other steps were performed to open the device.  the patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a neuron max sheath, navien 058 guide catheter, and phenom 27 microcatheter.
 
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Brand NamePIPELINE FLEX
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 Key11645970
MDR Text Key244867994
Report Number2029214-2021-00412
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
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,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-16
Device Catalogue NumberPED-500-16
Device Lot NumberB060745
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 Received08/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/28/2020
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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