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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-325-16
Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Ischemia (1942); Memory Loss/Impairment (1958); Nausea (1970); Paresis (1998); Dysphasia (2195); Dyskinesia (2363); Convulsion/Seizure (4406); Syncope/Fainting (4411); Unspecified Nervous System Problem (4426)
Event Date 04/18/2021
Event Type  Injury  
Manufacturer Narrative
Report sent in reference to medwatch mw5102232. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline embolization device was implanted into the left paraclinoid with few issues. Post-procedure there were no initial issues, but the patient was admitted to the emergency room at 8:30 am on (b)(6) 2021. The patient could not coordinate the thumb and pinky, and they were diagnosed with a stroke. The patient also experienced a seizure at 6:40 pm and experienced memory issues. The patient returned home with improvement, but then had multiple recurrent strokes. The patient was admitted to the icu with speech and walking difficulties. The physician gave 20 mg/day of dexamethasone, and the vitals were normal. The icu neurologist said the stent was leaching metal into the brain, but also said they were not sure what material would be leaching because there were seven materials in the stent. However the physician stated they had never heard of a stent leaching metal, and declared the other physician was wrong. The patient was discharged from the ica and the steroids were reduced to 18 mg/day with a plan to taper to 6 mg/day. The patient experienced subsequent psychosis and memory-loss. Concomitant medical plavix, aspirin, keppra, dexamethasone, tylenol.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12294910
MDR Text Key265621496
Report Number2029214-2021-00991
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberPED-325-16
Device Catalogue NumberPED-325-16
Device Lot NumberA654100
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 Received10/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2018
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: 08/09/2021 Patient Sequence Number: 1
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