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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 Ischemia (1942); Muscle Weakness (1967); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: 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. The device was used for an off label indication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Matthew b. Potts, michael c. Hurley, sameer a. Ansari, ali shaibani, scott r. Geraghty, thomas j. Grobelny, babak s. Jahromi, mechanical thrombectomy for delayed thrombosis of pipeline embolization device, world neurosurgery, volume 140, 2020, pages 237-240, issn 1878-8750, https://doi. Org/10. 1016/j. Wneu. 2020. 04. 202. Medtronic literature review found reported of patient complications in association with implantation of a pipeline embolization device (ped). The authors reviewed one case of a (b)(6), female patient treated for an unruptured fusiform aneurysm using a ped. The procedure was off-label due to the location of the implantation. The article does not state any technical issues during use of the pipeline. Six months post-procedure, occlusion of the aneurysm was confirmed via cerebral angiogram. Eighteen months post-procedure, the patient presented with acute onset of left-side weakness and a national institutes of health stroke scale (nihss) score of 10. At the time of her presentation with an acute ischemic stroke, computed tomography (ct) angiography demonstrated occlusion within the ped construct and ct perfusion showed a large region of ischemic penumbra within the right mca territory. A mechanical thrombectomy was performed, and reperfusion was achieved with a 2a reperfusion score. Two hours later, reocclusion of the ped was demonstrated. Another mechanical thrombectomy was performed and the modified thrombolysis in cerebral infarction (mtici) score was 2a again. The patient was put on dual antiplatelet therapy (dapt) with aspirin 81 mg daily and ticagrelor 90 mg twice daily. The patient remained neurologically intact and remained so at the 1 year follow up.
 
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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 Key10916666
MDR Text Key218710726
Report Number2029214-2020-01202
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2020
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 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: 11/29/2020 Patient Sequence Number: 1
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