MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 4X20; CATHETER, THROMBUS RETRIEVER

Catalog Number 90182

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

Patient Problem Embolus (1830)

Event Date 09/09/2015

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 left middle cerebral artery m1 segment.During the procedure, embolization to new territory occurred.Approximately two days later the patient was discharged to hospice.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, emboli 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 left middle cerebral artery m1 segment.During the procedure, embolization to new territory occurred.Approximately two days later the patient was discharged to hospice.No further information is available.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X20
• 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: 5835686
• MDR Text Key: 50813371
• Report Number: 0002954917-2016-00115
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Catalogue Number: 90182
• Device Lot Number: 37942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR