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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Intracranial Hemorrhage (1891); Hemorrhage, Intraventricular (1892)
Event Date 07/30/2018
Event Type  Death  
Manufacturer Narrative
The pipeline flex device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there does not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. Mdrs related to this event: 2029214-2018-00755 2029214-2018-00756. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report of a patient death after pipeline flex implantation. The patient underwent placement of multiple pipeline devices in the treatment of multiple, bilateral aneurysm in the internal carotid artery (ica). During the procedure, the devices were prepared as indicated in the ifu. The patient was administered dual antiplatelets and the patient's responsiveness to the antiplatelet regimen was tested. A pipeline flex with shield 4x25mm was placed on the left side; a pipeline flex 4x30mm and 3. 5x20mm were placed on the right side. There were no device issues reported. It was reported that three hours post-procedure, the patient developed intracranial hemorrhage (ich) and intraventricular hemorrhage (ivh). The patient underwent placement of an external ventricular drain (evd). The patient died within 72 hours of the procedure there are no procedural images available for review.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7831065
MDR Text Key118708161
Report Number2029214-2018-00756
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/21/2019
Device Model NumberPED-350-20
Device Lot NumberA363719
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 Received08/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2016
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: 08/29/2018 Patient Sequence Number: 1
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