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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Break (1069)
Patient Problems Paresis (1998); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Elsayed ga, chagoya g, bernstock jd, et al. Magnetic resonance imaging safety of retained tip and protective coils after faulty deployment of an intracranial pipeline embolization device: a case report.  world neurosurgery. 2019;129:221-224. Doi:10. 1016/j. Wneu. 2019. 06. 007. The case in this article was regarding (b)(6) year old female with a ruptured vertebral artery fusiform aneurysm just distal to the origin of the posterior inferior cerebellar artery. The rupture led to hydrocephalus and subarachnoid hemorrhage for the patient. It was reported that, during procedure. Only minimal torquing of the delivery system was required to disengage the distal pipeline, but the tip and protective coil fragmented from the delivery wire during deployment. This was noticed when the delivery microcatheter was advanced over the delivery wire after the deployment. Attempts to retrieve the capture coil were unsuccessful, and it remained within the p1 segment of the right pca. There were no other complications at the conclusion of the procedure. The device fragments remained in the patient. Postprocedure the patient¿s neurologic condition improved. However, as the patient became more alert, a new onset of a left upper extremity paresis was seen. 21 days post procedure the patient was following commands and their left upper extremity paresis started to improve. They were ultimately discharged to a rehabilitation facility, with plans for follow-up imaging at 3 months, but did not show due to relocation.
 
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Brand NamePIPELINE
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 Key9905961
MDR Text Key195546271
Report Number2029214-2020-00312
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem 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 Received03/09/2020
Was Device Evaluated by Manufacturer? No
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: 03/31/2020 Patient Sequence Number: 1
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