MAUDE Adverse Event Report: MICRO THERAPEUTICS INC. MEDTRONIC SOLITAIRE X 6MM X 40MM; CATHETER, THROMBUS RETRIEVER

Model Number SFR4-6-40-10

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2021

Event Type  malfunction  

Event Description

During endovascular treatment of acute ischemic stroke; intracranial mechanical thrombectomy with solitaire stent retriever, interventional radiologist fell the retriever wire loose tension abruptly.Further retraction of the retriever wire was without movement of the stent retriever device within the distal internal carotid artery and m1.These findings were consistent with a fractured stent retriever wire.Repeat contrast injection immediately after the retriever wire was removed from the intermediate catheter demonstrated patency of the proximal m1 branch now without visualization of the right a1 branch of the anterior cerebral artery.The proximal aspect of the fractured retriever wire was seen within the horizontal portion of the internal carotid artery.Multiple attempts were made to snare the fractured portion of the procedure wire with a 4 mm micro snare however these attempts unsuccessful.Repeat angiogram demonstrated occlusion of the proximal m1 due to the in-stent thrombosis.Trickle flow was seen through the right a1 branch of the anterior cerebral artery.At this time, further attempts for stent retrieval removal were deemed too risky to proceed due to risk of vessel rupture.The procedure was terminated at this time.At the conclusion of the study, the guide catheter was retracted to the external iliac artery for angiographic evaluation of the common femoral artery puncture site.Hemostasis at the puncture site was achieved with the angioseal hemostatic closure device.There were no immediate complications.

• Brand Name: MEDTRONIC SOLITAIRE X 6MM X 40MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS INC. ; dba ev3 neurovascular 9775 toledo way ; irvine CA 92618
• MDR Report Key: 12413279
• MDR Text Key: 270346115
• Report Number: MW5103668
• Device Sequence Number: 1
• Product Code: NRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: N/A
• Device Lot Number: B187462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 87