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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
Model Number NV UNK PIPELINE
Device Problem Unintended Movement (3026)
Patient Problems Paralysis (1997); Dysphasia (2195)
Event Date 09/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Keisuke sasaki, naoto kimura, michiko yokosawa, ryosuke doijiri, ken takahashi, takayuki sugawara, & teiji tominaga. (2020). Use of contralateral trans-anterior communicating artery snare to rescue lost access to a pipeline embolization device unsheathed in an aneurysm. ¿journal of neuroendovascular therapy,¿ 11, 508. Medtronic received a literature article in which the aim was to present pipeline related complication and its rescue strategy in use of vascular construction to treat large internal carotid artery aneurysms. In this case a (b)(6) female with a left ica aneurysm measuring 15mm in diameter was treated. The patient's presenting conditions include incomplete paralysis of the left oculomotor nerve. It was reported that, while collecting a delivery wire from the marksman, it interfered with the ped and the system migrated to the distal side, with intra-aneurysmal migration of the proximal side of the ped. It was impossible to enter the true lumen of the ped from the proximal side because the orifice of the stent faced the aneurysmal wall. Contralateral trans-acoma access to the ped was obtained through the distal ica. The microwire from the distal ica was connected with goose neck snares from the proximal ica. Pulling the snares to the proximal side, the ped was straightened and distal access was regained. Another ped was deployed such that it overlapped with the first ped to achieve vascular reconstruction. After awakening from general anesthesia, motor aphasia and paralysis of the right upper limb were noted. No high signal intensity suggestive of cerebral infarction was noted on magnetic resonance imaging diffusion-weighted imaging. The patient finally recovered from aphasia, but paralysis of the right upper limb remained after rehabilitation. The patient was referred to a rehabilitation hospital with a modified rankin scale score of 2.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12114614
MDR Text Key261689464
Report Number2029214-2021-00816
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
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: 07/04/2021 Patient Sequence Number: 1
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