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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-500-30
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2020
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 failed to open. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the right internal carotid artery. It was noted the patient's vessel tortuosity was moderate. It was reported that the distal segment of the pipeline (pli-10) failed to open. The pipeline was removed from the patient, and a second pipeline (pli-20) was used. The second pipeline failed to open in the middle section. The devices were not positioned in a bend, less than 50% had been deployed, it was unknown how many resheathing attempts were performed, and no additional steps were done to open the devices. The second pipeline was removed from the patient, and the third and fourth pipeline were deployed successfully. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results showed the aneurysm was covered. Ancillary devices include a neuronmax, phenom plus, phenom27.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10536680
MDR Text Key207049124
Report Number2029214-2020-00930
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
Report Date 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-30
Device Catalogue NumberPED-500-30
Device Lot NumberA993680
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 Received09/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2020
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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