MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PRO 18RO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

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

Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Event date: the exact date of the adverse event is unknown.All patients were treated between january 2011 and march 2012.This is 3 of 3 reports for this article.The device is not available.

Event Description

The article retrospectively compared the clinical outcome in patients who received thrombolytic therapy only with patients who underwent mechanical thrombectomy with or without additional thrombolysis.Patients in both groups had an acute anterior circulation occlusion and a thrombus length of at least 8mm.Forty consecutive patients (median age 71, range 20 - 83; 27 females) were treated with mechanical thrombectomy using retrieval devices in addition to standard stroke treatment.It was reported that the advancing microcatheter (subject device) perforated the target vessel distal to an m1 middle cerebral artery thrombus.The procedure was terminated and the patient remained asymptomatic for the resulting subarachnoid hemorrhage.No further details 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.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.However, vessel perforation and hemorrhage 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 article retrospectively compared the clinical outcome in patients, who received thrombolytic therapy only with patients who underwent mechanical thrombectomy with or without additional thrombolysis.Patients in both groups had an acute anterior circulation occlusion and a thrombus length of at least 8mm.40 consecutive patients (median age 71, range 20 ¿ 83; 27 females) were treated with mechanical thrombectomy using retrieval devices in addition to standard stroke treatment.It was reported that the advancing microcatheter (subject device) perforated the target vessel distal to an m1 middle cerebral artery thrombus.The procedure was terminated and the patient remained asymptomatic for the resulting subarachnoid hemorrhage.No further details provided.

• Brand Name: TREVO PRO 18RO MICROCATHETER
• 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: tara lopez ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 6035849
• MDR Text Key: 57681530
• Report Number: 0002954917-2016-00148
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K131437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90238
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• 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
• Treatment: TREVO PRO VUE (CONCENTRIC)
• Patient Outcome(s): Other