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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426)
Event Date 04/29/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that a patient underwent a procedure for pipeline flex implantation in the right internal carotid artery (ica) to treat an unruptured saccular aneurysm with max diameter of 5mm and neck diameter of 4mm. The distal landing zone was 2. 87mm; the proximal landing zone was 3. 35mm. Vessel tortuosity was very minimal. Dual antiplatelet treatment (dapt) was administered with pru level of 9. The patient had a relevant personal medical history of obesity, anxiety disorder, and previous aneurysms. Previous pipeline was placed on (b)(6) 2021 in the left ica and the patient was on brillenta 60mg bid since the placement of that pipeline. The patient recovered well from the first pipeline implantation procedure and the decision was made to treat the aneurysm on the right side. There were no device malfunctions or procedural issues. Access was flawless. The pipeline deployed well easily; no manipulation of the device was needed. Post-procedure angiography showed the pipeline deployment was clean - the device was we ll apposed to the patient's vessel walls and was diverting flow from the aneurysm as intended and expected. While waiting for the patient to wake up, the physician decided to check the status of the previously placed pipeline in the left ica. Some possible in-stent stenosis was observed but the patient had not had any symptoms so it was not considered to be threatening. The patient woke up from anesthesia and was fine through the night, passing all neuro checks. When prepared for discharge home the following morning, the physician discussed the findings of the stenosis in the initial pipeline. Upon hearing the news, the patient expressed feelings of having a panic attack. The physician gave anti-anxiety medication and allowed the patient time to calm down but this was not effective and the patient passed neuro assessment but had stroke symptoms so the physician decided to do computed tomography (ct) just to be safe. Ct was performed and infarct with complete occlusion was observed in the acutely placed pipeline in the right ica and the patient was sent to intervention. Additional aspiration procedure was performed to treat the stroke. The infarct was cleared but the patient had brain edema so the following day a hemicraniotomy procedure was performed. It was noted that at the time of the report the patient was alive but sedated and unresponsive and was being monitored. Ancillary devices: rist radial sheath, phenom plus guide catheter, phenom 27 150cm microcatheter.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11806275
MDR Text Key249993858
Report Number2029214-2021-00558
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-350-18
Device Catalogue NumberPED-350-18
Device Lot NumberB130805
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 Received06/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/10/2020
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: 05/11/2021 Patient Sequence Number: 1
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