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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2014
Event Type  Death  
Manufacturer Narrative
Bae, h. J. , park, y. K. , cho, d. Y. , choi, j. H. , kim, b. S. , <(>&<)> shin, y. S. Predictors of the effects of flow diversion in very large and giant aneurysms. Ajnr am j neuroradiol, 42:1099¿1103 (2021). Http://dx. Doi. Org/10. 3174/ajnr. A7085. This value is the average age 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Bae, h. J. , park, y. K. , cho, d. Y. , choi, j. H. , kim, b. S. , <(>&<)> shin, y. S. Predictors of the effects of flow diversion in very large and giant aneurysms. Ajnr am j neuroradiol, 42:1099¿1103 (2021). Http://dx. Doi. Org/10. 3174/ajnr. A7085 medtronic literature review found reported of patient complications in association with implantation of pipeline embolization devices to treat cerebral aneurysms. The purpose of this article was to investigate the treatment paradigm for very large and giant aneurysms that has recently changed to flow diversion, in light of the results of the pipeline for uncoilable or failed aneurysms trial. The effects of flow diversion were definitely unknown, and the study explored this topic and identified the predictors of such effects. There were 34 patients in the effect group (66. 7%, 34/51; no filling, 35. 3%, 18/51; remnant entry, 31. 4%, 16/5). The no-effect group comprised 17 patients(33. 3%, 17/51; subtotal filling, 29. 4%, 15/51; total filling, 3. 9% 2/51). The mean age of the effect group was lower than that of the no-effect group (51. 2 [sd, 14. 9] years versus 57. 8 [sd, 12. 8] years; p
=
. 126). The mean aneurysm size and neck diameter were 21. 9 (sd, 4. 3) mm and 10. 1 (sd, 4. 8) mm, respectively (effect group: 21. 4 [sd, 4. 1] mm, 9. 8 [sd, 4. 4] mm; no-effect group: 25. 4 [sd, 12. 7] mm, 13. 2 [sd, 15. 4] mm; p
=
. 231, p
=
. 385, respectively). The mean aneurysm size and neck diameters were larger in the no-effect group, but these differences did not reach statistical significance. The effect group was observed in 11/19 (57. 8%) aneurysms involving the infraclinoid internal carotid artery, 14/20 (70. 0%) aneurysms involving the supraclinoid internal car otid artery, 3/4 (75. 0%) aneurysms involving the anterior and middle cerebral arteries, and 6/8 (75. 0%) aneurysms involving the vertebrobasilar artery. Among all 51 patients, complications occurred in 7, including 4 deaths (3 delayed ruptures and 1 thromboembolic event) and 3 major c omplications (1 each of rupture, thromboembolic event, and aneurysm mass effect). The overall morbidity and mortality rates were 3. 9% (2/51) and 7. 8% (4/51), respectively. The article does not state any technical issues during use of the pipeline. The following intra- or post-procedural outcomes were noted: 1. Death of 4 patients (3 delayed ruptures and 1 thromboembolic event) 2. Rupture 3. Thromboembolic event 3. Aneurysm mass effect.
 
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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 Key12556750
MDR Text Key274201420
Report Number2029214-2021-01225
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P100018
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 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
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 Received09/16/2021
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: 09/30/2021 Patient Sequence Number: 1
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