MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 4X30; CATHETER, THROMBUS RETRIEVER

Catalog Number 90185

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

Patient Problem Embolus (1830)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure with the subject retriever for a clot located at the middle cerebral artery (mca) m1 and m2 segments.During the procedure, embolization to the a3 & a4 segments of the left pericallosal artery occurred.No further information is available.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure with the subject retriever for a clot located at the middle cerebral artery (mca) m1 and m2 segments.During the procedure, embolization to the a3 and a4 segments of the left pericallosal artery occurred.Unspecified medical management was performed and the outcome was reported to be resolved.An unknown time later the patient was discharged to a rehab facility.The event was reported to be related to the procedure and the device.No further information is available.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, embolus is a known risk associated with endovascular procedures and is 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

It was reported that the patient underwent a mechanical thrombectomy procedure with the subject retriever for a clot located at the middle cerebral artery (mca) m1 and m2 segments.During the procedure, embolization to the a3 & a4 segments of the left pericallosal artery occurred.Unspecified medical management was performed and the outcome was reported to be resolved.An unknown time later the patient was discharged to a rehab facility.The event was reported to be related to the procedure and the device.No further information is available.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X30
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 5769295
• MDR Text Key: 48761113
• Report Number: 0002954917-2016-00104
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Catalogue Number: 90185
• Device Lot Number: 38811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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 18 MICROCATHETER (CONCENTRIC)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR