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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Visual Impairment (2138); Loss of Vision (2139); Stenosis (2263); Thrombosis/Thrombus (4440)
Event Date 03/10/2022
Event Type  Injury  
Event Description
Medtronic received information that a patient treated with a ped2 pipeline had complication with stenosis or thrombosis and blindness, vision impairment, and ophthalmopathy. The patient was being treated for an unruptured, saccular aneurysm in the internal carotid artery (ica). C5 segment. On the right side. The aneurysm height is 3. 4mm and the max diameter was 6. 0mm. The dome diameter is 5. 7mm. The aneurysm neck is 2. 4mm. Greater curvature side. Antiplatelet therapy was administered.  implant date: (b)(6) 2021. Stenosis or thrombosis in the side branch vessels or parent arteries covered by the flow diverter. Associated symptoms: blindness, v ision/visual impairment, ophthalmopathy. Slight visual impairment due to branch retinal artery occlusion appeared after the surgery. Not severe. Causal relationship with device and procedure cannot be ruled out. No procedure was done. Outcome: recovered but with prognostic symptoms. Date of outcome: (b)(6) 2022.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key14030930
MDR Text Key289613743
Report Number2029214-2022-00591
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-450-16
Device Catalogue NumberPED2-450-16
Device Lot NumberB312854
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/15/2021
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: 04/06/2022 Patient Sequence Number: 1
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