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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 PED2-425-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Shaking/Tremors (2515); Thromboembolism (2654)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that 6 days post procedure the patient had tremor, numbness, and slight motor paresis of the left upper extremity. Brain ct scans showed a few hemorrhagic spots in the right hemisphere, and a brain mri showed numerous focal enhancing lesions in the right hemisphere, corresponding to multiple micro-emboli. It was stated that this was probably due to foreign body emboli. Cta/mra/dsa excluded the existence of stent thrombosis. There were no remarkable findings in the cerebral vessels. Patient symptoms were noticed 6 days post procedure. The patient's symptoms were relieved shortly after antiepileptic and corticosteroid medication were administered, with dual antiplatelet therapy also modified. The patient was undergoing treatment of a ruptured, saccular, right p-com aneurysm with a max diameter of 6mm and a neck width of 2mm. It was noted that the patient's vessel tortuosity was normal. The devices were prepared as indicated per the ifu. Dual antiplatelet treatment was administered, with a pru level of 34 seen. Post procedure angiographic results showed excellent stent apposition and residual aneurysm still filling. The initial procedure was without complication and was completed successfully. There was no alleged product issue. A pipeline was used due to residual aneurysm after coiling, but the coil used was unknown. Additional information received reported it was uncertain if the foreign body emboli was related to the pipeline device or accessory device(s). No additional surgical intervention was provided or scheduled. The brain mri that was done post-operatively was considered to be an additional intervention. The plan was to continue normal follow-up and post-operative treatment unless additional symptoms developed.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12036606
MDR Text Key265204293
Report Number2029214-2021-00756
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-425-10
Device Catalogue NumberPED2-425-10
Device Lot NumberB156636
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 Received06/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/04/2021
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: 06/21/2021 Patient Sequence Number: 1
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