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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 Stroke/CVA (1770); Paralysis (1997); Thrombosis/Thrombus (4440)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
Cagnazzo f, ahmed r, lefevre ph, derraz i, dargazanli c, gascou g, riquelme c, frandon j, bonafe a, costalat v. Flow modification on the internal carotid artery bifurcation region and a1 segment after m1-internal carotid artery flow diverter deployment. Journal of neurointervent surgery. 2020;12:1226¿1230. Doi:10. 1136/neurintsurg-2020-016051. Age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cagnazzo f, ahmed r, lefevre ph, derraz i, dargazanli c, gascou g, riquelme c, frandon j, bonafe a, costalat v. Flow modification on the internal carotid artery bifurcation region and a1 segment after m1-internal carotid artery flow diverter deployment. Journal of neurointervent surgery. 2020;12:1226¿1230. Doi:10. 1136/neurintsurg-2020-016051. Clinical and hemodynamic consequences of flow diverters extending from the m1 to the internal carotid artery (ica), covering the a1 segment, have rarely been investigated. The purpose of this article was to provide angiographic and clinical data about flow modifications on the covered a1. The authors reviewed 42 cases of a1 arteries covered with a single device. Of the 42 patients, the average age was 54 years, 35 were female and 7 were male. Flow diverters were successfully deployed from the m1 to the ica segment in all patients. The mean diameter of the covered a1 was 2. 1 mm (median 2. 2 mm, sd 0. 4, range 1. 2¿3. 5 mm). Immediately after flow diversion deployment, 20 (47. 6%) covered a1 showed slow flow because of the flow compensation from the contralateral side through a patent acoma. No cases of immediate occlusion were recorded. The overall rate of complications related to the m1-ica flow diversion was 4. 7%, with 2. 3% morbidity. The article does not state any technical issues during use of the pipeline. The following intra- or post-procedural outcomes were noted: after prasugrel discontinuation at 6 months, one patient developed a basal ganglia infarct related to the coverage of the m1 perforators; the patient partially recovered with an mrs score of 1 at the 12 month follow-up. One patient had an acute instant thrombosis which completely resolved after treatment with abciximab, without any neurological sequelae.
 
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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 Key13560138
MDR Text Key290453120
Report Number2029214-2022-00237
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
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
Is the Reporter a Health Professional? Yes
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: 02/18/2022 Patient Sequence Number: 1
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