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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM; CATHETER, CONTINUOUS FLUSH

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MICRO THERAPEUTICS, INC. DBA EV3 PHENOM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number UNK-NV-FG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aspiration/Inhalation (1725); Encephalopathy (1833); Dysphasia (2195); Cognitive Changes (2551); Syncope/Fainting (4411); Unspecified Nervous System Problem (4426)
Event Date 06/02/2023
Event Type  Injury  
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 information that patient treated in the embolise study had acute encephalopathy with neurological worsening.Cognitive decline, decreased level of consciousness and aphasia.The event required hospitalization.The event is not resolved.The event was possibly related to the procedure and not related to the device.Specify sdh location: frontal, parietal, tempora.L hematoma thickness: 22.5 mm.Midline shift: 2.7 mm.No other information was received.Additional information was received that the same patient experienced significant coughing when swallowing post procedure and a dobhoff naso-duodenal feeding tube (dht) was placed.It was reported that the patient experienced dysphagia.The event resulted in treatment and diagnostic tests were performed.The outcome was not recovered/resolved.The event was not associated with a seizure, decline in mrs and did not result from a device deficiency.The site assessed the event as not related to the device or procedure, however, the sponsor assessed the event as possibly related to the embolization procedure.It was noted that a phenom plus catheter was utilized in the procedure as well.The site reported that the event was caused by the disease under study.
 
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
Additional information was received that the dysphagia resulted in prolongation of hospitalization and percutaneous intervention.Gastronomy tube was placed due to aspiration and severe protein calorie malnutrition.Peg was placed on 2023-jun-15.Additionally it was reported that the patient had hospital delirium, no orientation, moans and groans, restless, agitated, picking at stuff if not sedated, and does not open eyes.Event was updated to life threatening.
 
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
Additional information was received that the clinical events committee adjudicated the events as possibly related to the mma embolization procedure.
 
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Brand Name
PHENOM
Type of Device
CATHETER, CONTINUOUS FLUSH
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 Key17128105
MDR Text Key317207293
Report Number2029214-2023-00924
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/17/2023
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-FG
Device Catalogue NumberUNK-NV-FG
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2023
Initial Date FDA Received06/14/2023
Supplement Dates Manufacturer Received06/29/2023
10/20/2023
Supplement Dates FDA Received07/05/2023
11/17/2023
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) Hospitalization;
Patient Age85 YR
Patient SexFemale
Patient Weight51 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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