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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER

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MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number SFR-6-30
Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  malfunction  
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the solitaire experienced resistance in the distal part of the rebar 27 microcatheter during delivery and the tip broke. The patient was undergoing treatment for an ischemic stroke located in the left internal carotid artery. The patient's baseline mrs, nihss, and tici scores were 2, 14, and 1 respectively. Post procedure these were 2, 1, and 3 respectively. The stroke onset to reperfusion time was 4 hours. It was reported that the microcatheter was sent to the inferior trunk of the middle cerebral artery. Angiography confirmed that it was in the true lumen of the blood vessel. The solitaire was delivered through the microcatheter, which had obvious resistance and could not be delivered in place. After pulling back the solitaire stent, it was found that the tip of the solitaire was broken.  the solitaire was replaced, and the patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu).
 
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Brand NameSOLITAIRE FR
Type of DeviceCATHETER, THROMBUS RETRIEVER
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key15094755
MDR Text Key304795875
Report Number2029214-2022-01226
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K113455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSFR-6-30
Device Catalogue NumberSFR-6-30
Device Lot NumberB277338
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2021
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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