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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 Occlusion (1984); Loss of Vision (2139); Stenosis (2263); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative

The device was implanted and not returned for analysis. Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. The reported adverse events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received report through literature review of ¿`plug and pipe¿ strategy for treatment of ruptured intracranial aneurysms¿ (brian m howard, jason m frerich, thomas p madaelil, jacques e dion, frank c tong, c michael cawley, jonathan a grossberg). 22 patients underwent acute phase coiling of an aneurysm after asah; 21 patients suffered sah from a ruptured saccular aneurysm, while 1 was treated for an iatrogenic, medial wall, carotid cave ica pseudoaneurysm caused during endoscopic, endonasal pituitary adenomectomy. The population was predominantly female (n=19, 86%). The median age of the study population was 57 years (iqr 49. 3, 64. 5; range 36¿83). All aneurysms were primary coiled at the time of their asah without any intraoperative rupture or thromboembolic complications. Complications, as a result of flow diversion, occurred in two (9%) patients. One patient suffered monocular blindness as a consequence of ophthalmic artery occlusion. The second suffered an inferior epigastric artery avulsion and external iliac artery dissection that required an operative bypass by vascular surgery. No patients suffered re-hemorrhage in the interval between coiling and ped placement, or after ped placement. No patient in the study population died. On follow up, there was note of one case in-stenosis.

 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8778615
MDR Text Key150684589
Report Number2029214-2019-00720
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 07/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received06/13/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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