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 04/02/2017

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

The patient underwent a thrombectomy procedure to restore blood flow to the right mca-m1 segment.Post procedure the patient achieve a tici score of 2b, and at 24 hours, a nihss of 38.Approximately 7 days post the index procedure, the patient was assessed having a nihss of 12 and a mrs of 4.The patient was discharged to another short term general hospital 10 days post the index procedure.Embolization to new territory (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent had occurred in the anterior cerebral artery (aca).No adverse events associated with the aca-ent were reported.No further information is available.

Manufacturer Narrative

Executive summary was updated to reflect additional information received on 10-oct-2017 indicating that the high nihss post recanalization was due to the fact that the patient was intubated therefore is not representative.After the extubation the patient's nihss score was 16.

Event Description

The patient underwent a thrombectomy procedure to restore blood flow to the right mca-m1 segment.Post procedure the patient achieve a tici score of 2b, and at 24 hours, a nihss of 38.The study facility reported that the high nihss post recanalization was due to the fact that the patient was intubated therefore is not representative.After the extubation, the patient's nihss score was 16 and approximately 7 days post the index procedure, the patient was assessed having a nihss of 12 and a modified ranquin scale (mrs) of 4.The patient was discharged to another short term general hospital 10 days post the index procedure.Embolization to new territory (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent had occurred in the anterior cerebral artery (aca).No adverse events associated with the aca-ent were reported.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 remains implanted; 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 restore blood flow to the right mca-m1 segment.Post procedure the patient achieve a tici score of 2b, and at 24 hours, a nihss of 38.The study facility reported that the high nihss post recanalization was due to the fact that the patient was intubated therefore is not representative.After the extubation, the patient's nihss score was 16 and approximately 7 days post the index procedure, the patient was assessed having a nihss of 12 and a modified ranquin scale (mrs) of 4.The patient was discharged to another short term general hospital 10 days post the index procedure.Embolization to new territory (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent had occurred in the anterior cerebral artery (aca).No adverse events associated with the aca-ent were reported.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: 6916142
• MDR Text Key: 88239856
• Report Number: 0002954917-2017-00090
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K150616
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 90185
• Device Lot Number: 60338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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: 75 YR