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

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.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL 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 Key: 7725533
• MDR Text Key: 115189924
• Report Number: 2029214-2018-00673
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR