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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-400-20
Device Problems Unintended Movement (3026); Activation Failure (3270)
Patient Problems Muscle Weakness (1967); Dysphasia (2195)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the 4x20 stent was taken to the tip of the microcatheter and initially tip coil pushed halfway out. Then the stent was opened distally, the system was drawn back into the internal carotid artery (ica), but the stent was at an awkward angle pointing towards the anterior choroidal. Approximately 1-2 fifths of the stent open resheathed, and repositioned several times. Once the physician was satisfied with the position, more of the device was pushed out, but the vessel narrowed and attempts were difficult. While trying to open the middle and proximal segments, the distal end dropped back and needed repositioning. Eventually a good position was achieved, the mid-section opened through the bend to almost fully deploy. The physician was not satisfied with the final few mm that would deploy into a slightly wider segment and possibly beunopposed to the vessel wall. A 4. 5x14 was used instead. However, the same issue occurred: the mid-section appeared to twist. After re-sheathing and repositioning multiple times, the device was removed. A non-medtronic product was used and deployed well. Following deployment of the final stent, on table computerized tomography (ct) was performed, and it appeared the patient had cortical staining (hypoperfusion). The patient was extubated at the end of the procedure, and it took a long time for the patient to respond. Eventually they began coughing with no verbal response, weaker right leg and arm movement. The patient was eventually able to obey commands after a lengthy period of time. Increased fluids were give, and the patient was placed on itu for observation overnight. The patient was undergoing surgery for treatment of an amorphous, ruptured aneurysm of the left ica with a max diameter of 6 mm and a 3. 3 mm neck diameter. It was noted the patient's vessel tortuosity was severe. All devices were prepared per the instructions for use (ifu). Ancillary devices include a fabuki 80cm 8f sheath, cat 5 115 cm guide catheter, headway 27, synchro 14, phenom 27 x2.
 
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Brand NamePIPELINE VANTAGE WITH 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 Key12298802
MDR Text Key265808401
Report Number2029214-2021-00995
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 08/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-400-20
Device Catalogue NumberPED3-027-400-20
Device Lot NumberB186465
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 Received08/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2021
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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