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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-400-14
Device Problems Activation, Positioning or SeparationProblem (2906); Migration (4003)
Patient Problem Aneurysm (1708)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that post-op follow up showed that the pipeline had either foreshortened or migrated proximally leaving the distal neck of the aneurysm exposed and was still filling.  the cause of the issue was unknown. The pipeline had been implanted at the intended location, and angiographic results post procedure had shown the pipeline was fully covering the aneurysm neck. Full wall apposition had been achieved, and the pcom side branches were covered.  the patient did not experience any symptoms. The patient was retreated with coiling, and their status was said to be alive with no injury. The devices were prepared according to the instructions for use (ifu). The patient was undergoing treatment for an unruptured, saccular aneurysm in the patient's posterior communicating artery. The max diameter was 4. 5mm, and the neck diameter was 3mm. The patient's vessel tortuosity was normal. Dual antiplatelet treatment was administered.
 
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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 Key11579637
MDR Text Key242717704
Report Number2029214-2021-00350
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 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-14
Device Catalogue NumberPED-400-14
Device Lot NumberUNKNOWN
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 Received04/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2021 Patient Sequence Number: 1
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