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 04/15/2017

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

The patient underwent a thrombectomy procedure to treat the occluded m2 segment.It was reported that during the procedure, new embolization occurred in the left anterior cerebral artery (aca).No adverse event associated with the new embolization was reported.Post the thrombectomy procedure, the patient achieved a tici score of 2b, and at 24 hours post procedure, the patient was assessed having a nihss of 16.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, embolus is a known risk associated with endovascular procedures and is noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

The patient underwent a thrombectomy procedure to treat the occluded m2 segment.It was reported that during the procedure, new embolization occurred in the left anterior cerebral artery (aca).No adverse event associated with the new embolization was reported.Post the thrombectomy procedure, the patient achieved a tici score of 2b, and at 24 hours post procedure, the patient was assessed having a nihss of 16.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: tara lopez ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 6609600
• MDR Text Key: 76588541
• Report Number: 0002954917-2017-00055
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 90185
• Device Lot Number: 61265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 07/16/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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: 48 YR