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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 Intracranial Hemorrhage (1891)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
Zhonghua lv, yong zhu, wei wang, qiangjun wu, wen li, qiang li & liang xu (2019) comparison of two endovascular interventions with low-profile visualized intraluminal support or pipeline embolization device in middle cerebral arterial aneurysms patients, journal of investigative surgery, doi: 10. 1080/08941939. 2019. 1670883. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Zhonghua lv, yong zhu, wei wang, qiangjun wu, wen li, qiang li & liang xu (2019) comparison of two endovascular interventions with low-profile visualized intraluminal support or pipeline embolization device in middle cerebral arterial aneurysms patients, journal of investigative surgery, doi: 10. 1080/08941939. 2019. 1670883 medtronic literature review found reported of patient complications in association with aneurysm embolization with the pipeline embolization device (ped). The purpose of this article was compare efficacy and safety of low-profile visualized intraluminal support (lvis) stent and pipeline embolization device (ped)-assisted endovascular interventions in patients with middle cerebral arterial aneurysms. The authors reviewed 63 ped cases of patients: the average age was 47 years, 35 were female and 28 were male. The article does not state any technical issues during use of the ped. In addition, the raymond grade was recorded immediately after surgery: class 1 (41 patients), class 2 (12 patients), and class 3 (10 patients). The modified rankin scale (mrs) score was also recorded immediately after surgery: 0 (41 patients), 1 (14 patients), 2 (4 patients), 3 (4 patients). The mrs score was recorded 6 months after surgery: 1 (47 patients), 2 (10 patients), 3 (6 patients), recurrence (5 patients). Recurrence was defined as hemorrhage of the aneurysm, or aneurysms that need surgical treatment again.
 
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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 Key11017147
MDR Text Key225569150
Report Number2029214-2020-01316
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
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 Received11/18/2020
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: 12/16/2020 Patient Sequence Number: 1
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