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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); Intracranial Hemorrhage (1891)
Event Date 03/27/2020
Event Type  Injury  
Manufacturer Narrative
See manufacturer report # 2029214-2020-01338 for a related report from this article. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Dmytriw aa, kapadia a, enriquez-marulanda a, et al. Vertebral artery aneurysms and the risk of cord infarction following spinal artery coverage during flow diversion. Journal of neurosurgery. March 2020:1-10. Doi:10. 3171/2020. 1. Jns193293 medtronic literature review found a report of patient complications in association with pipeline embolization devices (peds). The purpose of this article was to assess the association between coverage of the anterior spinal artery (asa), posterior spinal artery (psa), or lateral spinal artery (lsa) ostia when placing flow diverters in distal vertebral arteries (vas) and clinical outcomes, with emphasis on cord infarction. A review of 60 patients with 63 va and posterior inferior cerebellar artery aneurysms treated with flow diverters were reviewed. Fifty-eight of the 60 procedures used peds. Thirty-nine (65. 0%) patients were female with a median age of 57. 7 years. The article does not state any technical issues during use of the ped. The following intra- or post-procedural outcomes were noted: death occurred in 5 cases (8. 6%), due either to initial sah or to intracranial hemorrhagic complication after the flow diverter placement. Of these, 3 deaths (5. 0%) were a direct consequence of the device placement. Nine (15. 0%) patients developed cerebral thromboembolic complications and 4 of them (7. 4%) were symptomatic. From the overall sample of patients, cerebellar infarcts occurred in 6 cases (10. 0%), pca territory infarct in 3 cases (5. 0%), and brainstem infarct in 2 cases (3. 3%). From the 9 patients who had thromboembolic complications, 2 had infarcts in two or more territories (one patient had brainstem, cerebellum, and pca infarctions, and the other patient had brainstem and cerebellum infarctions). Symptomatic thromboembolic complications occurred in 2 (22. 2%) of 9 cases with acutely ruptured aneurysms versus 2 (4. 0%) of 50 nonacutely ruptured cases. Six (10. 0%) patients developed hemorrhagic complications, all of which were symptomatic. From the overall sample of patients, the types of hemorrhagic complications were subarachnoid hemorrhage (sah) in 3 (5. 0%) cases, intraparenchymal hemorrhage (iph) in 2 (3. 3%) cases, and iph and subdural hemorrhage (sdh) in 1 (1. 7%) case. Symptomatic hemorrhagic complications occurred in 3 (30. 0%) cases with acutely ruptured aneurysms versus 3 (6. 0%) nonacutely ruptured cases. Two cases (3. 5%) were re-treated.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11033936
MDR Text Key224395447
Report Number2029214-2020-01339
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,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
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 Received11/18/2020
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: 12/17/2020 Patient Sequence Number: 1
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