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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Subarachnoid (1893); Ischemia (1942); Thrombosis (2100); Loss of Vision (2139); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report through literature review of ¿surgical and endovascular comprehensive treatment outcomes of unruptured intracranial aneurysms: reduction of treatment bias¿ (christopher s. Ogilvy, noah j. Jordan, luis c. Ascanio, alejandro a. Enriquez-marulanda, mohamed m. Salem, justin m. Moore, ajith j. Thomas) a pipeline embolization device was used to treat 248 (37. 7%) patient. Of the 66 adverse event that have been reported only 6 have been alleged to have been patient that were treated with a pipeline embolization device. One subarachnoid hemorrhage (sah) occurred during the placement of the pipeline. The mrs for this patient was reported to be 0-2. Two patients experienced ischemic (cerebellar stroke) after the pipeline was placed. The mrs for these patients was reported to be 0-2. One ischemic (permanent visual field loss) after the pipeline was placed. The mrs for this patient was reported to be 0-2. Two patients experienced in-stent thrombosis that was treated with eptifibatide and a subarachnoid (sah) developed after procedure. The mrs for these patients was reported to be 0-2. Most of the patients were women (77. 5%), with a median patient age of 59 years. Two patients that were treated with a pipeline device were reporter to have an mrs of 3-6 post the intervention.
 
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Brand NamePIPELINE
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 Key8754647
MDR Text Key149833337
Report Number2029214-2019-00666
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/17/2019
Was Device Evaluated by Manufacturer? No
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: 07/02/2019 Patient Sequence Number: 1
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