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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK FLEX
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Diestro, j. D. B. , parra-farinas, c. , zetchi, m. A. , spears, j. , <(>&<)> marotta, t. R. (2020). The pop (pull on pipe) maneuver: a technical note for rescuing a prolapsed pipeline device. Journal of stroke and cerebrovascular diseases, 29(4). Https://doi. Org/10. 10 16/j. Jstrokecerebrovasdis. 2020. 104647. Medtronic review of the literature article found described a case in which, when retrieving the pipeline embolization device (ped) pushwire, there was shortening of the proximal end of the ped stent resulting in prolapse of the ped stent into the aneurysm. The "pull on pipe (pop)" maneuver was utilized to address the prolapse of the first ped. A second ped was deployed inside the lumen of the prolapsed ped with gentle traction to restore the initial flow diverter into its proper position. The maneuver also allows for the immediate deployment of the second ped to improve proximal purchase and overall construct stability. The second ped was then completely deployed proximally. Final cerebral angiograms and cone beam computed tomography (ct) demonstrated adequate positioning and wall apposition of both peds and beginning aneurysmal flow stasis. The patient was undergoing a procedure for flow diversion treatment of a giant aneurysm of the right internal carotid artery (ica) cavernous sinus segment. The patient had symptoms of seizures, diplopia on rightward gaze, right eye ptosis and miosis, and limited abduction of right side - findings consistent with right cranial nerve 6 palsy and accompanying horner's syndrome. Post-operatively, the patient experienced transient severe right eye pain for the first month which was alleviated with an initial course of dexamethasone and pain medication. Neuroimaging at 4 months post-operative showed marked regression of aneurysm filling and the patient's cranialnerve symptoms were notably improved from pre-operative status.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13448030
MDR Text Key294664849
Report Number2029214-2022-00156
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
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

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