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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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MICRO THERAPEUTICS, INC. PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Rupture (2208); Collapse (2416)
Event Date 05/14/2019
Event Type  Death  
Event Description
The patient was a patient in the neurology clinic since approximately 6 years and was initially referred for headaches, tingling, and visual loss.She was diagnosed with "weekly classic migraine".In (b)(6) 2018, she experienced significant and constant visual changes.Mri showed 2 cerebral aneurysms and patient was referred to neurosurgery provider, who recommended a 2-staged approach (left-sided pipeline stent followed by a right-sided procedure 2-3 months later).The patient underwent a procedure.8 days later, patient collapsed at home and was found to have rupture of the left aneurysm.She ultimately passed the next day.
 
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Brand Name
PIPELINE
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC.
5290 california avenue
irvine CA 92617
MDR Report Key9647202
MDR Text Key176978261
Report Number9647202
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPED-475-25
Device Lot NumberA612922
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2020
Date Report to Manufacturer01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age16060 DA
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