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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 PED2-500-12
Device Problems Positioning Failure (1158); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
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 entire system moved proximal while advancing the pipeline in the microcatheter. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica. The max diameter was 3mm, and the neck diameter was 2mm. The patient's vessel tortuosity was moderate. The landing zone was 3. 91mm distal and 4. 87mm proximal. It was reported that the pipeline was loaded and advanced into the microcatheter. As the pipeline approached the distal ica the entire system fell down/back. The sheath somewhat, the guide catheter more so, and the microcatheter more significantly. The physician attempted to advance the entire system back to a location where they could deploy the pipeline but they were unable to advance the microcatheter and pipeline into the m1. As a result, they removed the microcatheter and pipeline and re-accessed the m1 with microguide wire and a new microcatheter. The original pipeline could not be used, and the case was successfully completed with a new pipeline.  the patient did not experience any injury or complications. Angiographic results post procedure were said to be good. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a tracstar sheath, phenome plus guide catheter, and phenome 27 microcatheter.
 
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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 Key12215449
MDR Text Key263441725
Report Number2029214-2021-00911
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
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-12
Device Catalogue NumberPED2-500-12
Device Lot NumberB213559
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 Received07/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2021
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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