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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Paralysis (1997); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported in manufacturer report # 2029214-2022-00558. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that pipeline patients experienced hemiparesis following the procedure. It was reported that the doctor had previously noticed 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. In at least on case he claimed that the patient demonstrated some hemispatial-neglect and hemiparesis. A balloon was not used in the procedures. The doctor stated that diffusion imaging can show contact agent outside the lumen of the vessel. The doctor suspected that a response to the hydrophilic coating may have caused the issue. 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.
 
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Brand NamePIPELINE
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 Key14245251
MDR Text Key291290308
Report Number2029214-2022-00737
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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
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: 04/28/2022 Patient Sequence Number: 1
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