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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 Problem Aneurysm (1708)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kamide t, misaki k, uno t, yoshikawa a, uchiyama n, nakada m. Extracranial-intracranial high-flow bypass as a rescue therapy for inc omplete cerebral aneurysm occlusion after flow diversion: a case report. Surgical neurology international. 2021;12:57. Doi:10. 25259/sni_836_2020 medtronic literature review found a report of patient complications in association with a pipeline procedure. The article does not state any technical issues during use of the pipeline device. The purpose of this article was to provide a case report for an extracranial-intracranial (ec-ic) high-flow bypass procedure as a rescue therapy. The following intra- or post-procedural outcomes were noted: the patient was initially treated with endovascular coil embolization. However, cerebral angiography performed 2 years after endovascular coiling showed coil compaction and persistent filling into the aneurysm, and the patient underwent placement of a pipeline device. The distal end of the stent was positioned just proximal to the posterior communicating artery (pcoa). Cerebral angiography performed 1 year after insertion of the pipeline demonstrated reduced filling into the aneurysm, but not complete occlusion. Imaging performed 2 years after insertion of the pipeline revealed increased filling into the aneurysm, and it was believed that it would be difficult to cease antiplatelet therapy under these conditions. However, the patient was required to stop antiplatelet therapy to receive surgical treatment for severe osteoarthritis of the knee. To cease antiplatelet therapy promptly, it was decided to perform ica trapping with ec-ic high-flow bypass as a rescue therapy. Angiography following this procedure revealed that pcoa flow through ec-ic high-flow bypass was preserved and complete occlusion of the aneurysm was achieved.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12156609
MDR Text Key261695120
Report Number2029214-2021-00851
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,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
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: 07/13/2021 Patient Sequence Number: 1
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