MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

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

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Vasoconstriction (2126); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the patient experienced a subarachnoid hemorrhage after a procedure where a marksman microcatheter was used.The patient was undergoing treatment for thrombus collection for an occlusion of the right m2 superior trunk in the middle cerebral artery.It was reported that thrombus collection was performed using an embotrap stent retriever, balloon catheter, and suction catheter.A marksman microcatheter was induced distally to the m2 superior trunk using a guidewire.Afterwards, the suction catheter was induced towards the distal end of m1, the embotrap was deployed from the distal end of the m2 superior trunk.An attempt was made to retract it into the suction catheter but there was a catch, so the suction catheter and the embotrap were collected externally as a unit.At that time, a distal embolization occurred in the m3 region.A collection was performed using the embotrap, balloon catheter, and suction catheter for the distal embolism, but when collecting the embotrap and suction catheter stress was applied to the blood vessel and vessel shift was observed.Thrombus collection was successful and complete patency was achieved, but a mild spasticity occurred in the middle cerebral artery.Subarachnoid hemorrhage occurred after the surgery which resulted in left hemiplegia.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12313624
• MDR Text Key: 266227137
• Report Number: 2029214-2021-01012
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability