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); Vascular Dissection (3160)

Event Date 12/21/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the patient died due to hemorrhaging from dissection following a procedure where a marksman microcatheter had been used.It was reported that the patient developed cerebral infarction associated with middle cerebral artery (m1) occlusion and was transferred to the hospital.The concomitant devices used were a guidewire, guide catheter, microcatheter (marksman), and balloon catheter.The microcatheter lowered was to the guide catheter position.An attempt was made to remove the thrombus by deploying the embotrap thrombi removal device in the occluded site; however, the arteriosclerosis was severe and there was strong resistance.Because the thrombus could not be removed with the embotrap alone, the microcatheter was raised to the point near the thrombus and the thrombus was collected.Embotraps were deployed three times in total; however, the distal side of the thrombus could not be removed, so thro mbi removal was performed using another company's device.Subsequently, dissection occurred on the distal side of the thrombus, and hemorrhaging was observed.Subsequently, hemostasis could not be achieved and the procedure could not be continued.The patient died after surgery.The attending physician stated that the event was not caused by a problem with the product itself, but rather from the patient's background (severe arteriosclerosis) and the progress until the start of treatment, the situation might have been quite severe.Hemorrhaging due to dissection led to death.The patient was undergoing treatment for acute cerebral infarction.The patient's vessel tortuosity was strong.The access vessel was the middle cerebral artery, which was 2.3mm in diameter.The device was prepared and flushed as indicated in the instructions for use (ifu).

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13101538
• MDR Text Key: 282887031
• Report Number: 2029214-2021-01678
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death