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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Hemorrhage, Subdural (1894)
Event Date 09/26/2019
Event Type  Death  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cherian, j. , srinivasan, v. , froehler, m. T. , grossberg, j. A. , cawley, c. M. , hanel, r. A. , ¿ kan, p. (2019). Flow diversion for treatment of intracranial aneurysms in pediatric patients: multicenter case series. Neurosurgery. Doi: 10. 1093/neuros/nyz380. Medtronic literature review found reports of patient complications after pipeline implantation. Case 3: a (b)(6)-yr-old girl underwent coiling in the treatment of subarachnoid hemorrhage and a 5-mm right internal carotid artery terminus aneurysm. Interval imaging 2 weeks later revealed new intraventricular hemorrhage and aneurysmal recurrence. This recurrence was treated with additional coil embolization and ped placement. She was treated with eptifibatide during the procedure and loaded with aspirin and clopidogrel after ped placement. The operation was uncomplicated, and she awoke at her neurologic baseline. Despite this, the patient declined suddenly the following day. Repeat head ct revealed extensive subarachnoid, intraparenchymal, and subdural hemorrhages. She ultimately died several days later.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9927210
MDR Text Key186527933
Report Number2029214-2020-00334
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2020
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/05/2020 Patient Sequence Number: 1
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