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 Embolus (1830); Intracranial Hemorrhage (1891)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that the patient underwent a thrombectomy procedure with the subject retriever for a clot located at the left middle cerebral artery m1 and p1 segment.Approximately 24 hours post procedure, a computed tomography (ct) scan indicated intracerebral hemorrhage in the insula.In addition, emboli to new territory was observed in the left a4 segment.No treatment was performed.The patient was later discharged to a short term general hospital.The event was reported to be related to the procedure and unrelated to the device.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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, hemorrhage 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 complications has been assigned to the event.The reported emboli to new territory was not confirmed within the analysis of the procedure¿s imaging scans.

Event Description

It was reported that the patient underwent a thrombectomy procedure with the subject retriever for a clot located at the left middle cerebral artery m1 and p1 segment.Approximately 24 hours post procedure, a computed tomography (ct) scan indicated intracerebral hemorrhage in the insula.In addition, emboli to new territory was observed in the left a4 segment.No treatment was performed.The patient was later discharged to a short term general hospital.The event was reported to be related to the procedure and unrelated to the device.

Manufacturer Narrative

Additional information received indicated that the patient had circulatory arrest and died on (b)(6) 2016.The physician's opinion that was reported indicated that the patient's death was unrelated to the device or the procedure.

Event Description

It was reported that the patient underwent a thrombectomy procedure with the subject retriever for a clot located at the left middle cerebral artery m1 and p1 segment.Approximately 24 hours post procedure, a computed tomography (ct) scan indicated intracerebral hemorrhage in the insula.In addition, emboli to new territory was observed in the left a4 segment.No treatment was performed.The patient was later discharged to a short term general hospital.The event was reported to be related to the procedure and unrelated to the device.

• 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: 5633802
• MDR Text Key: 44478312
• Report Number: 0002954917-2016-00078
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 90182
• Device Lot Number: 38892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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
• Patient Age: 78 YR