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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 GOOSENECK SNARE CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 GOOSENECK SNARE CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The gooseneck micro snare was used on 5 of the 18 patient population in the study. Case 1 had a retrieval complication of thromboembolism and neurological effect with an outcome of severe disability. Case 2 had a retrieval complication of thromboembolism with an outcome of death. Case 7 had no retrieval complication but had an outcome of death. Case 11 had a hemorrhagic retrieval complication and neurological effect with an outcome of severe disability. Case 14 had no retrieval complication but had an outcome of minor neurological effect with good recovery. It was reported in the literature article, coil migration during or after endovascular coiling of cerebral aneurysms, that a retrospective analysis of the clinical and radiological data of patients who underwent cerebral aneurysm coiling complicated by coil migration at five neuroendovascular centres in the united states, canada, and france between 2008 and 2018. This retrospective study involved 18 patients that met the study criteria. Patients managed conservatively (5/18, 28%) did well. Thromboembolic and/or hemorrhagic complications were noted in 6/10 migration patients treated by endovascular modalities and in all migration patients who underwent surgical treatment (4/4). Three deaths occurred (3/18, 17%) related to high hunt and hess grade subarachnoid hemorrhage. It was concluded that coil migration is an uncommon but important complication of cerebral aneurysm coiling. Small aneurysms, aspect ratio 1. 6, and small coils are significant risk factors. Endovascular treatment, such as using a stent retriever, can be considered for procedural, proximal migration, and/or in cases of vessel occlusion. Delayed or distal migration should be managed conservatively.
 
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Brand NameGOOSENECK SNARE
Type of DeviceCATHETER, PERCUTANEOUS
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
toni o'doherty
parkmore business park west
galway 
 
091708734
MDR Report Key10141953
MDR Text Key195602511
Report Number2029214-2020-00540
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970668
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 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
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 Received05/15/2020
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: 06/11/2020 Patient Sequence Number: 1
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