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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 PED2-425-18
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Therapeutic Response, Decreased (2271); Insufficient Information (4580)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient underwent re-treatment on (b)(6) 2020 for the treated aneurysm due to the residual aneurysm. The patient was hospitalized for more than 24 hours, and then went into endovascular surgical treatment. Post-procedure angiography of the initial implant showed incomplete neck coverage, significant stasis, and raymond and roy class 3 classification. It was stated the patient presented a very interesting situation: chronic occlusion of the left internal carotid artery (ica) and a ruptured aneurysm at the choroidal right ica segment (dorsal choroidal, very close to the ica t). The aneurysm neck was 1-2 mm proximal to the right ica without jailing the anterior communicating (acom) artery or middle cerebral artery (mca). However, the margin for deployment error was very small. It was also noted that because of the difference in arterial diameter, the flow diversion stent (fds) tends to fall and opened below the aneurysm neck level. On a recent follow-up, the pi detected the first fds failed to cover the aneurysm opening and proceeded to add a second fds in the optimal location at that time. It was determined the reported event was probably an index procedure failure, and not related to the device. Post-procedure angiography of the re-treatment showed successful treatment, wall apposition achieved, neck coverage achieved, complete stasis, and raymond and roy class 1 classification. The patient was undergoing surgery for re-treatment of a saccular, previously ruptured aneurysm of the right internal carotid artery c7 with a max diameter of 3. 8 mm and a 4. 3 mm neck diameter. The aneurysm previously ruptured on (b)(6) 2020 and was treated with coil embolization. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 76 on (b)(6) 2020.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10606471
MDR Text Key209383781
Report Number2029214-2020-00985
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/08/2020
Device Model NumberPED2-425-18
Device Catalogue NumberPED2-425-18
Device Lot NumberA411849
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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