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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number UNK-NV-SOLITAIRE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/14/2021
Event Type  Death  
Manufacturer Narrative
A2.The reported patient age (71 years) is representative of the mean age of all patients included in the study.A3.The reported patient sex (female) is representative of the majority of patients included in the study.Separate reports will be submitted for react catheter and serious adverse patient events.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
Dossani, r.H., waqas, m., baig, a.A., cappuzzo, j.M., popoola, d., rai, h., monteiro, a., levy, a., hashmi, e., davies, j.M., levy, e.I., & siddiqui, a.H.(2021).Walrus balloon guide catheter for stroke intervention: technical considerations and clinical outcomes.World neurosurgery, 152, e144¿e148.Https://doi.Org/10.1016/j.Wneu.2021.05.051.Medtronic review of the literature article found review of 57 patients who underwent mechanical thrombectomy procedures to treat ischemic stroke.React-71 aspiration catheters were used in 22 cases and react-68 aspiration catheters were used in 16 cases.Solitaire stent retrievers were used in 30 cases.However, it was not specified in which cases any other medtronic devices were used.There were no device malfunctions reported in the article.The article reviewed first-pass effectiveness (fpe), defined as modified thrombolysis in cerebral infarction (mtici) score of 2c and 3; an average of 1.57 passes +/- 1.16 passes were made.36 patients had a final mtici of 2c or 3.19 patients had a final mtici of 2b, and 2 patients had a final mtici of 0-2a.It was noted that one patient died during index hospitalization.The cause of death was not reported.
 
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Brand Name
UNKNOWN SOLITAIRE
Type of Device
CATHETER, 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 Key16872613
MDR Text Key314612559
Report Number2029214-2023-00741
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNK-NV-SOLITAIRE
Device Catalogue NumberUNK-NV-SOLITAIRE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2023
Initial Date FDA Received05/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
Patient SexFemale
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