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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-475-25
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Death (1802); Rupture (2208)
Date of Event 05/01/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
Date of death is approximate.Event date approximate.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent a procedure for a left-sided pipeline stent.Eight days later, the patient collapsed at home and was found to have a rupture of the left aneurysm.The following day, the patient passed away.It was stated the device malfunctioned and was clarified to mean the device did not do what it was supposed to do.The patient was undergoing surgery for treatment of a large, left oa aneurysm.
 
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Brand Name
PIPELINE FLEX
Common Device Name
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key9678490
Report Number2029214-2020-00106
Device Sequence Number11361873
Product Code OUT
UDI-Device Identifier00847536016774
UDI-Public00847536016774
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P100018.S011
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/13/2021
Device Model NumberPED-475-25
Device Catalogue NumberPED-475-25
Device Lot NumberA612922
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date02/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient Age44 YR
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