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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-375-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)
Event Date 02/24/2016
Event Type  Injury  
Manufacturer Narrative

The device involved in the event will not be returned as it was implanted in the patient; therefore the event cause could not be determined. Correspondence has been sent out for additional information on event and details on physician. If additional information is received, then a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that patient was confirmed to have non-serious adverse event of dissection and perforation of parent artery one day post uneventful embolization treatment with medtronic flow diverter device. There were no adverse events or complications noted during the procedure. There was causal relationship to the equipment and procedure as it could not be denied. The adverse event was resolved the same day it was confirmed. No treatment was given. At seven day follow up, there were no symptoms and mrs was 0. The patient had 1 month, 6 month, and 1 year follow up with administration of aspirin and clopidogrel. No symptoms were seen and the mrs was 0. Then patient had 2 years and 3 years follow up with clopidogrel administration. There were no symptoms, but mrs was 1. The patient was undergoing embolization treatment of a saccular aneurysm measuring 10. 9mm x 4mm located in the c3 cavernous segment of the right internal carotid artery (ica). The patient had history of first-degree relative ruptured cerebral 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
9496801345
MDR Report Key9685167
MDR Text Key188890387
Report Number2029214-2020-00117
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP100018.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 02/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/16/2018
Device MODEL NumberPED-375-20
Device LOT NumberA091555
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
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: 02/09/2020 Patient Sequence Number: 1
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