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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-500-35
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Death (1802); Therapeutic Response, Decreased (2271)
Date of Event 08/01/2019
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
Medtronic received a report that the pipeline did not do what it was supposed to do.The patient was undergoing surgery for treatment of an aneurysm in the left intracranial terminus it was reported that the pipeline was used with no issues reported intra-op, and the patient did well post-op.However, the aneurysm bled two days later and the patient passed away.No additional information was reported.
 
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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 Key9952010
Report Number2029214-2020-00358
Device Sequence Number654843
Product Code OUT
UDI-Device Identifier00847536016903
UDI-Public00847536016903
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 other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/12/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date05/07/2022
Device Model NumberPED-500-35
Device Catalogue NumberPED-500-35
Device Lot NumberA827599
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/12/2020
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 Age82 YR
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