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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 Problem Activation Failure (3270)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 02/20/2017
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. The device involved in this event is not approved in the us; the device's brand name and model number are provided below. This report is being filed against a similar device, which is provided in section d. Brand name: pipeline flex with shield technology model number: ped2-500-16 mdrs related to this patient: 2029214-2019-00268, 2029214-2019-00269. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the core labs reported aneurysm (raymond roy class 3) was note in imaging that was performed 4 and 6 months post successful pipeline embolization procedure. It was reported that the first pipeline (ped2-500-15) was re-sheathed to improve wall apposition and the other pipeline (ped2-475-16) was re-sheath to help the distal end open. The patient was undergoing embolization treatment of 2 unruptured saccular aneurysms located in the ophthalmic segment of the right and right internal carotid artery. Post procedural angiography showed significant stasis and complete obliteration of the aneurysm.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8471939
MDR Text Key140623570
Report Number2029214-2019-00268
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/19/2018
Device Model NumberPED-500-16
Device Lot NumberA175736
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 Received03/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2015
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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