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 Problems Infarction, Cerebral (1771); Embolus (1830); Neurological Deficit/Dysfunction (1982)

Event Date 07/04/2016

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

The patient underwent thrombectomy procedure of the right m1 and m2 segments of the middle cerebral artery (mca).Post procedure the patient achieved a tici of 2b and at 24 hours the patient was assessed having a nihss of 15.The patient was discharged to inpatient rehab approximately 24 days post procedure with a nihss of 12 and a modified ranquin scale (mrs) of 4.Embolization to new (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent occurred.The affected territory was not disclosed and no adverse events associated with the ent were reported.No further information is available.

Manufacturer Narrative

Outcomes attributed to ae - updated to reflect medical management.Executive summary - updated to reflect ent location along with patient stroke and neurological deficit due to new stroke expiration and manufacturing dates - updated.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 and neurological deficit are known risks associated with endovascular procedures and are 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 thrombectomy procedure of the right m1 and m2 segments of the middle cerebral artery (mca).Post procedure the patient achieved a tici of 2b and at 24 hours the patient was assessed having a nihss of 15.The patient was discharged to inpatient rehab approximately 24 days post procedure with a nihss of 12 and a modified ranquin scale (mrs) of 4.Review performed by independent lab facility indicated that an ent occurred.The study facility confirmed the core lab finding indicating that after the first pass of the retriever in the mca, a right anterior cerebral artery (r-aca) clot developed.The patient experienced a moderate aca stroke that was treated with medical management.The relationship of the patient's ent was assessed as related to the procedure and device.It was reported that approximately 10 months post the index procedure the patient has left side severe weakness, dysarthria and a nihss of 10-12.No further information is available.

Manufacturer Narrative

Evaluation summary corrected to reflect stroke (infarction, cerebral).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, stroke and neurological deficit are known risks associated with endovascular procedures and are 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 thrombectomy procedure of the right m1 and m2 segments of the middle cerebral artery (mca).Post procedure the patient achieved a tici of 2b and at 24 hours the patient was assessed having a nihss of 15.The patient was discharged to inpatient rehab approximately 24 days post procedure with a nihss of 12 and a modified ranquin scale (mrs) of 4.Review performed by independent lab facility indicated that an ent occurred.The study facility confirmed the core lab finding indicating that after the first pass of the retriever in the mca, a right anterior cerebral artery (r-aca) clot developed.The patient experienced a moderate aca stroke that was treated with medical management.The relationship of the patient's ent was assessed as related to the procedure and device.It was reported that approximately 10 months post the index procedure the patient has left side severe weakness, dysarthria and a nihss of 10-12.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: tara lopez ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 6601284
• MDR Text Key: 76290622
• Report Number: 0002954917-2017-00048
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2017

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: 03/28/2018
• Device Catalogue Number: 90182
• Device Lot Number: 39967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 07/16/2017; 07/16/2017
• Supplement Dates FDA Received: 08/03/2017; 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: No
• 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: 34 YR