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

Catalog Number 90184

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage, Subarachnoid (1893)

Event Date 07/24/2015

Event Type  Death  

Manufacturer Narrative

The device was disposed in the hospital.

Event Description

It was reported that the patient underwent mechanical thrombectomy to remove a clot from the left internal carotid artery using the subject retrieval device.Complete revascularization of the left ica was achieved with a thrombolysis in cerebral infarction (tici) score of 2b.One (1) hour post procedure a subarachnoid hemorrhage (sah) in the treated territory occurred resulted in a stroke.There was no additional treatment performed.The next day, the patient died.The physician stated that there was no causal relationship between the sah and the subject device due to the retrieval device worked as intended during the procedure.However, the reported sah was related to the procedure due to imaging showed a sight bleeding immediately after the procedure.

Manufacturer Narrative

Correction: the event description - corrected.The device history record review confirms that the device met all material, assembly and performance specifications.The device was not available for analysis.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Hemorrhage, stroke and death are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

Event Description

It was reported that the patient underwent mechanical thrombectomy to remove a clot from the left internal carotid artery using the subject retrieval device.Complete revascularization of the left ica was achieved with a thrombolysis in cerebral infarction (tici) score of 2b.One (1) hour post procedure a subarachnoid hemorrhage (sah) in the treated territory occurred resulted in a stroke.There was no additional treatment performed.The next day, the patient died.The physician believed that the index stroke "itself by a wide range of brain ischemia have contributed to the death." the physician stated that there was no causal relationship between the sah and the subject device due to the retrieval device worked as intended during the procedure.However, the reported sah was related to the procedure due to imaging showed a sight bleeding immediately after the procedure.

• Brand Name: TREVO PROVUE
• 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: 5224704
• MDR Text Key: 31195045
• Report Number: 0002954917-2015-00122
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K122478
• 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
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 90184
• Device Lot Number: 37698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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): Death; Other
• Patient Age: 82 YR