MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 3X20; CATHETER, THROMBUS RETRIEVER

Catalog Number 90183

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

Patient Problem Embolus (1830)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

This is the 2nd of 2 reports filed for this event.The subject device is not available.

Event Description

The patient underwent a a thrombectomy procedure to treat the left internal carotid t bifurcation.Post procedure the patient achieved a tici score of 2b, and at 24 hours, the patient was assessed having a nihss of 19.The patient was discharged to inpatient rehab approximately five days post procedure with a nihss of 22 and a modified ranquin scale (mrs) of 5.Almost three months post the index procedure, and study completion, the patient was at home with a mrs of 2.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 occurred.The affected territory was not disclosed and no adverse events associated with the 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 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 left internal carotid t bifurcation.Post procedure the patient achieved a tici score of 2b, and at 24 hours, the patient was assessed having a nihss of 19.The patient was discharged to inpatient rehab approximately five days post procedure with a nihss of 22 and a modified ranquin scale (mrs) of 5.Almost three months post the index procedure, and study completion, the patient was at home with a mrs of 2.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 occurred.The affected territory was not disclosed and no adverse events associated with the ent were reported.No further information is available.

• Brand Name: TREVO XP PROVUE RETRIEVER 3X20
• 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: 6601282
• MDR Text Key: 76307876
• Report Number: 0002954917-2017-00047
• 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
• 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: 04/28/2017
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• 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: 07/14/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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
• Treatment: CONCENTRIC BGC 9 F (CONCENTRIC); TREVO XP PROVUE RETRIEVER 4X20 (CONCENTRIC)
• Patient Outcome(s): Other
• Patient Age: 54 YR