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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Event Date 09/25/2021
Event Type  Injury  
Event Description
Hosoo, h. , ishikawa, e. , tsuruta, w. , sato, m. , ito, y. , hayakawa, m. , takigawa, t. , marushima, a. , suzuki, k. , hyodo, a. , & amp; matsumaru, y. (2022). Antiplatelet therapy and periprocedural risk factor analysis for pipeline embolization device treatment of unruptured internal carotid artery aneurysms: a retrospective, multicenter analysis. World neurosurgery, 157. Https://doi. Org/10. 10 16/j. Wneu. 2021. 09. 109 summary: aneurysm treatment using the pipeline embolization device has been established but appropriate maintenance of dual antiplatelet therapy (apt) is essential. This multicenter retrospective study assessed whether apt was properly adjusted for clopidogrel resistance and identified risk factors associated with periprocedural complications. Identified events: 12 patients had re-treatment procedures and 1 patient had an emergent case. 1 patient had stent thrombosis just after the procedure. 6 patients had symptomatic distal embolisms in the cerebral hemispheres during the procedure. 2 patients had occlusions of the retinal artery branches during the procedure. 1 patient had a delayed occlusion of the anterior choroidal artery covered by ped 7 days after treatment. 9 patients had periprocedural hemorrhagic complications, all of which occurred within 14 days after treatment, including 2 delayed aneurysmal ruptures, 1 delayed symptomatic remote intracerebral hemorrhage, 3 delayed asymptomatic remote intracerebral hemmorhages, and 3 delayed asymptomatic subarachnoid hemorrhages. 1 patient had a delayed aneurysmal rupture in the carotid-cavernous fistula, which was remediated by subsequent transvenous embolization. 4 patient's suffered morbidity due to periprocedural complications. Event notes: the mean aneurysmal maximum and neck sizes were 15. 35 7. 15 mm and 6. 80 2. 96 mm, respectively. Most of the treated aneurysms were located at paraclinoid or cavernous portions (90. 12%). Adjunctive coiling was performed in 50 aneurysms (30. 86%).
 
Manufacturer Narrative
Hosoo, h. , ishikawa, e. , tsuruta, w. , sato, m. , ito, y. , hayakawa, m. , takigawa, t. , marushima, a. , suzuki, k. , hyodo, a. , & amp; matsumaru, y. (2022). Antiplatelet therapy and periprocedural risk factor analysis for pipeline embolization device treatment of unruptured internal carotid artery aneurysms: a retrospective, multicenter analysis. World neurosurgery, 157. Https://doi. Org/10. 10 16/j. Wneu. 2021. 09. 109. This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Associated regulatory report #: 2029214-2022-00272.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13582297
MDR Text Key292564292
Report Number2029214-2022-00274
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,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2022
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

Patient Treatment Data
Date Received: 02/22/2022 Patient Sequence Number: 1
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