MAUDE Adverse Event Report: EV3 NEUROVASCULAR SOLITAIRE FR; FLOW RESTORATION

Model Number SFR-4-20

Device Problem Physical Resistance (2578)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Reocclusion (1985)

Event Date 07/14/2014

Event Type  Death  

Event Description

Treatment of an acute stroke.The anatomy of the patient was medium in tortuosity and the vessels were narrow.On (b)(6) 2014, the patient underwent mechanical thrombectomy.During the procedure, it was reported the solitaire was delivered to the m1/m2 and retrieved after ten minutes.Thrombus was retrieved; however, there was more to be removed.Another pass was made to retrieve more thrombus and after 5 minutes, the physician confirmed the vessel was revascularized and decided to remove the device from the patient.Upon retrieving the device, slight resistance was experienced, but this resistance was also experienced during the retrieval of the device the first time so the physician continued retrieving the device.Shortly after, the resistance was no longer felt and the stent detached from the proximal marker.Due to stent detaching from the proximal marker and not being visible through angiography, it was decided to use another device (penumbra 4 max) to continue with the thrombectomy for the third time in the same vessel.The thrombus received this time was very small.The physician waited 10 minutes in order to monitor the condition; however, the vessel re-occluded from the distal m1 due to the remaining thrombus.For this reason, it was decided to use a coronary stent to capture the thrombus, but failed because the catheter could not be delivered to the target area.Spasm was confirmed at the area of the detached solitaire stent, but the physician confirmed the vessel was revascularized and the procedure was completed.The patient's symptom of agnosia was also improving and the patient was transferred to the icu (intensive care unit) at 22:15 and started antihypertensive therapy and antithrombocyte oral therapy.On (b)(6) 2014, the patient expired.Ct (computed tomography) revealed a hemorrhage due to the basal ganglia and it was decided that the hemorrhage was related to the primary disease.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains in the patient.(b)(4).

• Brand Name: SOLITAIRE FR
• Type of Device: FLOW RESTORATION
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4037011
• MDR Text Key: 15817533
• Report Number: 2029214-2014-00482
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2016
• Device Model Number: SFR-4-20
• Device Lot Number: 9866915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2014
• 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): Death; Disability
• Patient Age: 80 YR