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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 Rupture (2208)
Event Date 07/13/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Bender, m. T. , young, r. W. , zarrin, d. A. , campos, j. K. , caplan, j. M. , huang, j. , tamargo, r. J. , lin, l. M. , colby, g. P. , & coon, a. L. (2020). Twisting: incidence and risk factors of an intraprocedural challenge associated with pipeline flow diversion of cerebral aneurysms. Neurosurgery. Https://doi. Org/10. 1093/neuros/nyaa309. "abstract background: pipeline embolization device (ped; medtronic) ¿twisting¿ manifests with the appearance of a ¿figure 8¿ in perpendicular planes on digital subtraction angiography. This phenomenon has received little attention in the literature, requires technical precision to remediate, and has potential to cause ischemic stroke if not properly remediated. Objective: to report incidence, risk factors, and sequelae of ped twisting and to discuss techniques to remediate a ped twist. Methods: case images were reviewed for instances of twisting from a prospectively maintained, institutional review board-approved cohort of patients undergoing flow diversion for cerebral aneurysm. Results: from august 2011 to december 2017, 999 ped flow diverting stents were attempted in 782 cases for 653 patients. A total of 25 ped twists were observed while treating 20 patients (2. 50%, 25/999). Multivariate analysis revealed predictors of twisting to be: large and giant aneurysms (odds ratio (or)
=
9. 66, p
=
. 005; or
=
27. 47, p <. 001), increased ped length (or
=
1. 14, p <. 001), and advanced patient age (or
=
1. 07, p
=
. 002). A p-value of. 05 or less was deemed to be statistically significant. Twisted peds were able to be remediated 75% of the time, and procedural success was achieved in 90% of cases. Ped twisting was not found to be a significant cause of major or minor complications. However, at long-term follow-up, there was a trend towards poor occlusion outcomes for the cases that encountered twisting. Conclusion: twisting is a rare event during ped deployment that was more likely to occur while treating large aneurysms with long devices in older patients. While twisting did not lead to major complications in this study, remediation can be challenging and may be associated with inferior occlusion outcomes. " the study involved review of cases occurring at a single facility between august 2011 and december 2017. 782 procedures involving 653 patients occurred during which 999 pipelines were attempted to be placed. However, the final study information was regarding only the cases in which twisting of the pipeline was observed; this occurred with 25 pipeline devices in 20 cases. Average age of all patients included in the study was 56; the average age of patients who had twisting of the pipeline during the procedure was 67. A majority of patients (85%) in the study who had twisting of the pipeline during the procedure were female. Anatomic complexity was more frequently seen in cases with twisting, including significant cervical ica tortuosity (67% vs 31% in those without twisting) and grade iii or iv cavernous anatomy (50% vs 30% in those without twisting). Higher incidence of twisting also occurred more frequently in longer stents. 1 patient died 4 months post-operative following delayed aneurysm rupture.
 
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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 Key10929585
MDR Text Key219100391
Report Number2029214-2020-01216
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
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 NumberNOT-RPT
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 Received11/13/2020
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: 12/01/2020 Patient Sequence Number: 1
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