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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD45020
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported that during the procedure the stent (subject device) did not open and could not be deployed fully.The device was replaced and the procedure was completed successfully.The patients medical condition was good and there were no clinical consequences to the patient.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use and continuous flush was set up and maintained throughout the clinical procedure.There was no damage noted the stent or the stent delivery wire (sdw).The size of the stent was appropriate for the treatment site at the internal carotid artery (ica).The issue was noticed during use of the device on the patient.An excelsior xt-27 guide catheter was used to advance the stent delivery system.The guide catheter was flushed prior to insertion of the stent delivery system.The guide catheter rhv was adequately opened to allow insertion/ advancement of the stent delivery system and the stent delivery system was flushed with saline prior to use.The stent did not experience friction when moving the system over the guidewire.Excessive force was not applied at any point while advancing the stent within the microcatheter and the position of the stent was confirmed under fluoroscopy.There was no resistance encountered between the stent delivery system and the guide catheter as it was advanced to the lesion.The stent delivery system was able to be advanced to the lesion and there was no resistance encountered when attempting to deploy the stent.The stent delivery system was repositioned 3 times in an attempt to deploy the stent.The stent delivery microcatheter was retracted in a continuous movement while maintaining the position of the stent delivery wire.After removal, the physician attempted to deploy the stent on the table (outside the patient¿s body) and it opened well.There was 0% percentage stenosis and calcification at the lesion however the patient¿s anatomy was severely tortuous.The physician feels that the anatomy, the curve of the ica may have contributed to the reported event.As per the additional information, the patient¿s anatomy was severely tortuous and the physician feels that the anatomy, the curve of the ica may have contributed to the reported event, therefore an assignable cause of procedural factors will be assigned to the reported event of stent failed/unable to open (when not implanted) and stent partial deployment, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.H3 other text : device not returned for evaluation.
 
Event Description
It was reported that during the procedure the stent (subject device) did not open and could not be deployed fully.The device was replaced and the procedure was completed successfully.The patients medical condition was good and there were no clinical consequences to the patient.
 
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Brand Name
SURPASS EVOLVE 4.5MM X 20MM - CE
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11962991
MDR Text Key255323028
Report Number3008881809-2021-00231
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/08/2023
Device Catalogue NumberFD45020
Device Lot Number22285012
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR XT-27 CATHETER (STRYKER)
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