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 01/29/2016

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports for this event.The subject device was disposed of at the hospital.

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 territories (a1, a2 and a3 segment) occurred; therefore, another retriever device was used to remove the emboli from the new territories.The procedure was completed successfully and the patient was later discharged to a rehabilitation hospital.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 analysis cannot be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.There is also no indication that the subject device malfunctioned.However, embolus is a known risk associated with such procedures and noted as such in the directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication has been assigned to the 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 territories (a1, a2 and a3 segment) occurred; therefore, another retriever device was used to remove the emboli from the new territories.The procedure was completed successfully and the patient was later discharged to a rehabilitation hospital.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 left middle cerebral artery m1 segment.During the procedure, embolization to new territories (a1, a2 and a3 segment) occurred; therefore, another retriever device was used to remove the emboli from the new territories.The procedure was completed successfully and the patient was later discharged to a rehabilitation hospital.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: 5510541
• MDR Text Key: 40677786
• Report Number: 0002954917-2016-00050
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132641
• 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,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Catalogue Number: 90182
• Device Lot Number: 39095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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; Required Intervention
• Patient Age: 79 YR