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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 6X25; CATHETER, THROMBUS RETRIEVER
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CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 6X25; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number 90186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Embolus (1830)
Event Date 02/10/2016
Event Type  Injury  
Manufacturer Narrative
This is 1st of 2 reports filed for this event.The subject device is not available.
 
Event Description
The patient underwent a thrombectomy procedure achieving a tici score of 2b, and at 24 hours post procedure, a nihss of 21.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.No adverse event was reported associated with the ent.The patient was reported to have died due to respiratory failure approximately six days post the index procedure.No further information is available.
 
Manufacturer Narrative
Executive summary - updated with additional information.Patient code - updated to reflect additional information.The device history record (dhr) review cannot be performed because the lot number was not provided.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available; the cause of the reported issue cannot be determined.However, embolus and stroke 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 a thrombectomy procedure achieving a tici score of 2b, and at 24 hours post procedure, a nihss of 21.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.Mri performed on the same day showed acute infarcts in the left middle cerebral vascular territory and left anterior cerebral artery distribution.The patient did not experience symptoms resulting from the acute infarcts compare to the initial stroke symptoms.No medical treatment was administered due to the lack of change in clinical presentation.No adverse event was reported associated with the ent.However, the patient was reported to have died due to respiratory failure, and the presenting condition pre-procedure approximately six days post the index procedure.No further information is available.
 
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Brand Name
TREVO XP PROVUE RETRIEVER 6X25
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 Key6601410
MDR Text Key76308420
Report Number0002954917-2017-00051
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/26/2017
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 Catalogue Number90186
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/03/2017
Initial Date FDA Received05/31/2017
Supplement Dates Manufacturer Received06/30/2017
Supplement Dates FDA Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TREVO PROVUE 4X20 (CONCENTRIC)
Patient Outcome(s) Other;
Patient Age82 YR
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