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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-250-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Paralysis (1997); Swelling/ Edema (4577)
Event Date 03/15/2022
Event Type  Injury  
Event Description
Medtronic received a report that a pipeline patient experienced hemiparesis following the procedure. The patient was undergoing treatment for an unruptured, recurrent neck aneurysm located in the right anterior communicating artery that had been previously coiled aneurysm. The patient was known to have fibromuscular dysplasia (fmd) in the proximal internal carotid artery. The max diameter was 2. 75mm, and the neck diameter was 3. 5mm. The patient's vessel tortuosity was severe. The landing zone was 2. 7mm distal and 2. 5mm proximal.  dual antiplatelet treatment was administered. It was reported that the patient was treated with verapamil due to the proximal fmd. The pipeline was placed without incident or technical difficulties. However, upon follow up the next day, the patient was unable to move their left arm and also had some hyperperfusion. The doctor suspected that a response to the use of the pipeline or the hydrophilic coating of the phenom 27 microcatheter may have caused the issue. The doctor had seen this previously, with extravasation of fluid and swelling from the parent treated vessel directly distal to the placement of the pipeline 3-13 hours following implant. In all cases the patients recovered with no neurological deficits. A balloon was not used in the procedure. The doctor stated that diffusion imaging can show contact agent outside the lumen of the vessel. Other possible causes considered were the duration of the cases, use of too much contrast, and that the use of verapamil in a diseased vessel could induce fluid extravasation in some cases. No conclusive conclusion was determined.  it was noted that the device was being used off-label as it was placed in the anterior communicating artery.  angiographic results post procedure showed the device was well apposed throughout its length, and there was no endoleak.  the devices were prepared according to the instructions for use (ifu).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13984638
MDR Text Key291634416
Report Number2029214-2022-00558
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-250-10
Device Catalogue NumberPED2-250-10
Device Lot NumberB311800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/13/2021
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: 04/01/2022 Patient Sequence Number: 1
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