MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER

Model Number SFR2-6-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolus (1830)

Event Date 05/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis as it was discarded at the site.The patient had a critical stenosis of the right internal carotid artery measuring greater than 90%.The use of solitaire is contraindicated in this patient.Per solitaire instruction for use: use of the solitaire¿ fr revascularization device is contraindicated under these circumstances: patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the solitaire¿ fr revascularization device.Distal embolization including to a previously uninvolved territory is a known inherent risk of solitaire procedure and is documented in the solitaire fr instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.

Event Description

Medtronic received information that a patient experienced embolization to new territory and distal emboli during a solitaire procedure.The patient was treated for a complete right internal carotid artery occlusion at the carotid bulb.The solitaire fr device was deployed from the m1 middle cerebral artery (mca) into the right carotid terminus.After several minutes of dwell time, the solitaire device was simultaneously retracted through the cello.There was a note of significant thrombus on the device.Angiogram post first pass with the solitaire device revealed critical stenosis of the right internal carotid artery measuring greater than 90%; however, there was a slow antegrade filling.There is note of an m1 occlusion of the right mca as well as a2 right anterior cerebral artery occlusion.This is due to fragmentation of the right carotid terminus thrombus.The stenosis was treated with a stent and balloon angioplasty.Another mechanical thrombectomy was used for the remainder of the procedure.Right common carotid artery angiogram post carotid stenting and angioplasty as well as final thrombectomy showed tici2b reperfusion with a residual thrombus in an m4 brach of the superior division of the middle cerebral artery.The other middle cerebral artery branches are now reperfused, as well as the anterior cerebral artery branches.No solitaire device issue was reported during the procedure.The patient did not experience a neurological decline.It was reported that the patient clinical status was improved significantly.Baseline nih stroke scale (nihss) was 18.Five days post treatment, the patient was discharge with nihss of 3 and mrs of 1.90 day post treatment, the mrs was reported to still be a 1.

• Brand Name: SOLITAIRE FR2
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5272899
• MDR Text Key: 32858602
• Report Number: 2029214-2015-05190
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123378
• 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
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2017
• Device Model Number: SFR2-6-30
• Device Lot Number: A046090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Date Device Manufactured: 01/21/2015
• 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
• Patient Age: 00049 YR