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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVCIE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271)
Event Date 07/12/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report of a "nice" lesion with hemorrhagic complications. The adverse event resulted in retreatment and hospitalization for 3 days, but did not result in new or worsening neurological deficits. As a result of the issue the patient was given medication. This was noted to be a mild serious adverse event and the patient is currently recovering. The site noted this as probably related to the procedure, study and device, and unlikely related to the patient's pre-existing condition. The patient's medical history includes embolization of a ruptured right pca aneurysm.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVCIE
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 Key8928634
MDR Text Key155500974
Report Number2029214-2019-00871
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/10/2020
Device Model NumberPED-425-18
Device Catalogue NumberPED-425-18
Device Lot NumberA489379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/11/2017
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: 08/23/2019 Patient Sequence Number: 1
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