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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 Problems Intracranial Hemorrhage (1891); Thromboembolism (2654)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
Mcavoy mb, cappuzzo jm, stapleton cj, et al. Long-term follow-up results of the smart coil in the endovascular treatment of intracranial aneurysms. Interventional neuroradiology. 2021;27(2):200-206. Doi:10. 1177/1591019920956890. 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Mcavoy mb, cappuzzo jm, stapleton cj, et al. Long-term follow-up results of the smart coil in the endovascular treatment of intracranial aneurysms. Interventional neuroradiology. 2021;27(2):200-206. Doi:10. 1177/1591019920956890 medtronic literature review found reported of patient complications in association with the pipeline embolization device (ped) used for flow diversion with adjunctive coiling. The purpose of this article was to detail the long-term experience of a single institution using the non-medtronic smart coil among patients with intracranial aneurysms (ias). The authors reviewed 105 cases of patients treated for 106 ias. Of the 105 patients, the average age was 60. 0 years, 74 were female and 31 were male. Forty-nine (46. 7%) aneurysms were ruptured upon presentation, and 16 (14. 2%) aneurysms treated with smart coils were recurrent. Only 10 patients were treated by means of flow-diversion with coiling using the ped. The article does not state any technical issues during use of the ped. The article does not specify which post-operative complications belonged to which treatment type and if the ped was used with those patients. The following intra- or post-procedural outcomes were noted: 1. Two intra-procedural aneurysm ruptures occurred among a right supraclinoid internal carotid artery (ica) aneurysm and a left aca a1/a2 junction aneurysm. Several measures were taken to secure the aneurysm including balloon inflation, reversal of anticoagulation with protamine, rapid continued coiling with 3 additional aneurysms and administration of mannitol (once the aneurysm had been secured). The second rupture was very small with minimal contrast extravasation secondary to a small coil loop extruding through the aneurysm wall. Hemostasis was rapidly achieved with continued coiling and administration of protamine. 2. A third patient experienced an intraoperative thromboembolic complication. The degree of occlusion improved over subsequent contrast injection after administration of heparin. No intervention was taken to treat the embolism. 3. Six patient's required re-treatment. Refer to manufacturer report 2029214-2021-00859 for details pertaining to the related reportable event.
 
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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 Key12160561
MDR Text Key261308293
Report Number2029214-2021-00860
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
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
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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