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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Event Date 12/01/2020
Event Type  Death  
Manufacturer Narrative
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 [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Enomoto, y. , egashira, y. , matsubara, h. , yoshimura, s. , iwama, t. , long-term outcome of endovascular therapy for large or giant thrombosed intracranial aneurysms, world neurosurgery, volume 144, 2020, pages e507-e512, issn 1878-8750,https://doi. Org/10. 1016/j. Wneu. 2020. 08. 213. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Enomoto, y. , egashira, y. , matsubara, h. , yoshimura, s. , iwama, t. , long-term outcome of endovascular therapy for large or giant thrombosed intracranial aneurysms, world neurosurgery, volume 144, 2020, pages e507-e512, issn 1878-8750,https://doi. Org/10. 1016/j. Wneu. 2020. 08. 213 medtronic literature review found reported of patient complications in association with pipeline flex implantation for treatment of large or giant thrombosed intracranial aneurysms. The purpose of this article was to understand long-term clinical and angiographic outcomes of evt for lgtias, we retrospectively analyzed our single-center data on multimodality endovascular treatment (evt) for patients with large or giant thrombosed intracranial aneurysms (lgtias). The authors reviewed 31 cases of patients treated for lgtias using either a deconstructive treatment which included parent artery occlusion, trapping, or proximal occlusion with coils, or a reconstructive treatment which included coiling with or without vessel reconstructive devices, such as a stent or flow diverter. Of the 31 patients, 21 underwent a reconstructive treatment with use of a pipeline flex stent or a non-medtronic stent. The article does not differentiate which patients were treated with the pipeline flex as opposed to a non-medtronic stent. Of the 31 patients, the average age was 65. 8 years, 21 were female and 10 were male. The article does not state any technical issues during use of the pipeline flex. A favorable outcome at 12 months after the initial evt was obtained for 23 patients (74. 2%). The following intra- or post-procedural outcomes were noted: 1. Mortality by 12 months after the initial evt affected 2 patients due to procedure-related complications: 1 vessel perforation followed by fatal subarachnoid hemorrhage.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11842041
MDR Text Key251190471
Report Number2029214-2021-00591
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
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 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
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: 05/18/2021 Patient Sequence Number: 1
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