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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-425-25
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
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 was kinked/twisted in the proximal/mid section and failed to open in the middle. The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the right ica ophthalmic segment. The max diameter was 12mm, and the neck diameter was 9mm. The patient's vessel tortuosity was severe. The landing zone was 3. 06mm distal and 4. 15mm proximal.  dual antiplatelet treatment was administered, and the pru level was 61. It was reported that the middle part of the pipeline was positioned in a bend, and more than 50% had been deployed when it failed to open. The pipeline had been resheathed more than 2 times. There were no additional steps taken to open the device. The device was replaced, and the patient did not experience any injury or complications. Angiographic results post procedure showed stasis in the aneurysm, and the device was well apposed. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a bmx 80cm sheath, navien. 072 guide catheter, phenom 27 microcatheter, and aristotle 14 guidewire.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12506283
MDR Text Key272495034
Report Number2029214-2021-01183
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
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-25
Device Catalogue NumberPED-425-25
Device Lot NumberB009776
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 Received09/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/15/2020
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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