MAUDE Adverse Event Report: CONCENTRIC MEDICAL MC18L; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90044

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

Patient Problems Infarction, Cerebral (1771); Death (1802); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)

Event Date 06/25/2011

Event Type  Death  

Manufacturer Narrative

Subject device is not available.

Event Description

The patient underwent a thrombectomy procedure of the left m1 segment of the middle cerebral artery (mca); however, reperfusion could not be achieved.The physician performed clot disruption with the guidewire and microcatheter resulting in successful reperfusion; however, extravasation in the treated area was observed.No treatment was administered for the extravasation.A day post procedure, ct scan showed subarachnoid hemorrhage and intracerebral hemorrhage.The patient developed right paralysis and aphasia.Eleven days later the patient died from contralateral large cerebral infarction.No further details were provided.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, hemorrhage, cascading effects in relation to stroke-related complication and patient outcome of death are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

The patient underwent a thrombectomy procedure of the left m1 segment of the middle cerebral artery (mca); however, reperfusion could not be achieved.The physician performed clot disruption with the guidewire and microcatheter resulting in successful reperfusion; however, extravasation in the treated area was observed.No treatment was administered for the extravasation.A day post procedure, ct scan showed subarachnoid hemorrhage and intracerebral hemorrhage.The patient developed right paralysis and aphasia.Eleven days later the patient died from contralateral large cerebral infarction.No further details were provided.

• Brand Name: MC18L
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer (Section G): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer Contact: sanda dracic ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 5312315
• MDR Text Key: 33933701
• Report Number: 0002954917-2015-00136
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K072796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 85 YR