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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline flex device as not returned for evaluation as it was implanted in the patient. The pipeline flex device performed as intended; as indicated by successful deployment of the device in the intended landing zone to treat an aneurysm located in the internal carotid artery (ica). No device issue was reported during the procedure. Hemorrhage is a known inherent risk of endovascular procedure and is documented in the pipeline flex instruction for use. In addition, the physician stated that there was no causal relationship between the hemorrhage and the pipeline treatment. The cause is unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that 2 days post uneventful pipeline embolization procedure for an unruptured saccular cerebral aneurysm m easuring 16mm located in the internal carotid artery (ica) with a medtronic flow diverter device, the patient developed a hemorrhage distal to the target aneurysm. The distal and proximal landing zone was 4. 9mm x 5. 2mm. The patient was reported to be in a vegetative state. The patient had dual antiplatelet therapy (dapt) prior to the pipeline treatment and then was not placed on dapt until one week after the procedure. Two days after being placed on dapt, a hemorrhage occurred, and the patient was transferred to the hospital. The detail of treatment provided to the patient during transfer is not available. The physician stated that there was no causal relationship between the hemorrhage and pipeline treatment. The patient is currently symptomatic.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7661518
MDR Text Key113151324
Report Number2029214-2018-00598
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/1999
Device Model NumberPED-500-25
Device Lot NumberA232391
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 Received06/06/2018
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: 07/03/2018 Patient Sequence Number: 1
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