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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PROVUE; CATHETER, THROMBUS RETRIEVER
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CONCENTRIC MEDICAL TREVO PROVUE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number 90184
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Death (1802); Reocclusion (1985)
Event Date 05/10/2015
Event Type  Injury  
Manufacturer Narrative
The device was disposed in the hospital.
 
Event Description
It was reported that a mechanical thrombectomy using the subject device was performed to treat the left internal carotid artery (ica) occlusion due to an atherothrombosis.Complete revascularization of the left ica was achieved after the first pass with the retrieval device with a thrombolysis in cerebral infarction (tici) score of 2b.However, 1.5 hours after the procedure, a cerebral infarction due to the lesion re-stenosis was noted in the treated area.The cause of the lesion re-stenosis was likely atherosclerotic plaque.Percutaneous transluminal angioplasty (pta) was performed to treat the vessel occlusion and subsequent cerebral infarction and the patient was reportedly "recovered but not completely".In the physician's opinion, the cerebral infarction was not related to the device and /or procedure.Thirty six days post procedure, the patient died from the stomach cancer.The patient's death was not related to the index procedure and/or devices used.
 
Manufacturer Narrative
Corrections: 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.Stroke is a known and anticipated complications to these types of procedures and is noted in the labeling.Therefore, it was determined that the reported event was an anticipated patient complication.
 
Event Description
It was reported that a mechanical thrombectomy using the subject device was performed to treat the left internal carotid artery (ica) occlusion due to an atherothrombosis.Complete revascularization of the left ica was achieved after the first pass with the retrieval device with a thrombolysis in cerebral infarction (tici) score of 2b.However, 1.5 hours after the procedure, a cerebral infarction due to the lesion re-stenosis was noted in the treated area.The cause of the lesion re-stenosis was likely atherosclerotic plaque.Percutaneous transluminal angioplasty (pta) was performed to treat the vessel occlusion and subsequent cerebral infarction and the patient was reportedly "recovered but not completely".In the physician's opinion, the cerebral infarction was not related to the device and /or procedure.Thirty six days post procedure, the patient died from the stomach cancer.The patient's death was not related to the index procedure and/or devices used.
 
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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 Key5102221
MDR Text Key26720362
Report Number0002954917-2015-00091
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Followup
Report Date 09/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2016
Device Catalogue Number90184
Device Lot Number37322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Other; Required Intervention;
Patient Age66 YR
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