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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 FA-77250-10
Device Problem Migration (4003)
Patient Problems Pain (1994); Paresis (1998); Loss of Range of Motion (2032); Therapeutic Response, Decreased (2271); Hydrocephalus (3272)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
El ouadih y, coll g, jean b, et al. A rare complication of flow diverter: delayed migration causing aneurysm expansion and brainstem compression.  british journal of neurosurgery. May 2019:1-4. Doi:10. 1080/02688697. 2019. 1617406. The article was written regarding a (b)(6) year-old woman who was diagnosed with a large aneurysm (8. 7mm x 6 mm) of the right posterior inferior cerebellar artery (pica). The patient was implanted with the pipeline and discharged four days later, without unexpected events. However, two months later, they were admitted in neurosurgery for right shoulder and neck pain associated to right motor disturbance progressing in about four weeks. A right hemiparesis predominant to the upper limb was seen. Mri confirmed right medulla oblongata compression by the aneurysm, which had dramatically grown with partial thrombosis. Methylprednisolone 100 mg/day and withdrawal of acetylsalicylic acid and clopidogrel was prescribed. Five days later, they underwent emergency surgery because of acute clinical worsening with hemiplegia, phonation and swallowing difficulties with velum paresis. Surgery was performed and an unruptured pulsating thrombosed aneurysm was found, with the pipeline visible up to 5-mm away from the aneurysm sac in the inflow vessel. The inflow vessel was clipped because of the large size of aneurysm sac, enabling the dissection of outflow vessel. Then the outflow vessel, device free, was clipped enabling the opening of sac. The removal of thrombus and coils allowed immediate decompression of the brainstem. It was observed that the distal tip of ped was free in the circulating cavity of the aneurysm, causing the dramatic increase of size. The patient recovered completely within three months, without any additional drug prescription. The three-month postoperative mri confirmed the decompression.
 
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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 Key9863787
MDR Text Key190318805
Report Number2029214-2020-00276
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 03/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77250-10
Device Catalogue NumberFA-77250-10
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 Received03/09/2020
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

Patient Treatment Data
Date Received: 03/22/2020 Patient Sequence Number: 1
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