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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problems High Readings (2459); Activation Failure (3270)
Patient Problems Ischemia (1942); Occlusion (1984); Rupture (2208)
Event Type  Injury  
Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains in the patient; therefore, the cause of the event could not be determined. Correspondence has been sent out for more information to help with assessment of the event without the return of the device. Once all the needed information is received, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a rupture occurred during embolization with medtronic flow diverter of a giant supraclinoid aneurysm located in the internal carotid artery (ica). Prior to the event, a medtronic flow diverter (4. 75x25) was placed in the intended location and then followed by balloon percutaneous transluminal angioplasty (pta). After the event occurred, the rupture was arrested with medtronic coils. Ozagrel and heparin were administered to the patient. Six hours post procedure, the ica was occluded. A direct aspiration first past technique (adapt) was attempted with a 5 max catheter (2 passes) to recanalize the ica but the artery reoccluded after 10 minutes. Urokinase was administered locally followed by pta and stiff anticoagulation regimen was used (heparin). A second medtronic flow diverter was deployed to complete the procedure. The patient had multiple ischemic lesions at follow up. It was noted that the pru level was high (261), but they still proceeded to treat the patient with the flow diverter.
 
Manufacturer Narrative
The device was not returned for evaluation as it was implanted in the patient. No images were provided for review. The event occurred during treatment of a giant aneurysm located in the supraclinoid segment of the internal carotid artery (ica). As the device was still in use at the time this investigation was completed, no analysis could be performed. Therefore, the event cause and conformance to specification could not be determined. In addition, there was no indication that the event was related to a potential manufacturing issue and no device history review (dhr) was requested, so a dhr was not performed. Possible cause includes patient's vessel tortuosity. The investigation determined that this was a known failure mode, and therefore no formal investigation was required. All products are 100% inspected for damage and irregularities during manufacture. Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device. Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked. If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it. The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device. Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ if information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key7725533
MDR Text Key115189924
Report Number2029214-2018-00673
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
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 Received08/08/2018
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: 07/27/2018 Patient Sequence Number: 1
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