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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER; CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-NV-RFX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Dysphasia (2195); Rupture (2208); Dyskinesia (2363)
Event Date 04/18/2023
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 a report that the patient with previously coiled posterior communicating artery (pcom) aneurysm presented with remnant neck.A secondary aneurysm was also present at the distal end of the internal carotid artery (ica), just proximal to the terminus.The plan was to pipeline from the mca down to the distal clinoidal segment, covering both aneurysms with one device.The patient's ica anatomy was extremely tortuous.Regardless, the aristotle 14 and phenom 27 were navigated to the mca without issue.The wire was exchanged for the selected pipeline size (ped2-475-18).The physician began deployment in the mca and came around into the ica without issue.While crossing the neck of the pcom aneurysm (which was situated on the outer curve of a turn in the ica) , the device herniated into the neck of the aneurysm, causing hemorrhage.It was unclear if it was the pipeline that directly caused the bleeding or if the herniation moved the previously placed coils causing bleeding.The physician noticed the hermitization and conducted an angio before deploying the rest of the device.Bleeding was noticed at this point and the pipeline was immediately recaptured.Protamine was given and a balloon was brought up and inflated, occluding both the ica and the neck of the aneurysm.Bleeding stopped after a couple minutes.Physician then balloon coiled the aneurysm with two stryker coils.Upon conducting the final angio, the coils had secured the neck and there was no visible bleeding.Patient is being kept overnight and is be monitored to determine if/when a drain will be implanted.After the case the physician mentioned that he thought the anatomy was the driving factor for the hemorrhage.No device specific error was mentioned.The pipeline was used for an indication that is approved (on-label).The pipeline and any accessory devices were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right pcom with a max diameter of 3.5mm and a 2mm neck diameter.The landing zone was 4.5mm distally and 4mm proximally.It was noted the patient's vessel tortuosity was severe.It was noted that the patient experienced aneurysm rupture/intracranial hemorrhage.Dapt (dual antiplatelet treatment) was administered.Pru level was not checked because brillinta was used.Brillinta was disqualified as soon as rupture occurred.Protamine was give post rupture and prior to coiling.The angiographic result post procedure was the aneurysm neck was successfully coiled and there was no longer any signs of hemorrhage.Ancillary devices include a stryker infinity and navien.058 intermediate guide catheters, phenom 27 microcatheter, aristotle guidew ire, and stryker 3d coils.
 
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 event was resolved by coiling the rupture and the patient is recovering.The patient experienced headache and trouble speaking and moving related to the aneurysm/intracranial hemorrhage.The patient is currently admitted to a hospital for monitoring and follow-up imaging.
 
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Brand Name
REFLEX CATHETER
Type of Device
CATHETER, 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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key16809242
MDR Text Key313944817
Report Number2029214-2023-00694
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNK-NV-RFX
Device Catalogue NumberUNK-NV-RFX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2023
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) Required Intervention;
Patient SexMale
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