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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 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that during the procedure, flow diverter (subject device) partially deployed but it did not detach completely.In order to refine the placement, the physician tried to insert the subject flow diverter into the microcatheter, but it could only be retracted halfway with no way to go further.The physician was forced to pull the carrier microcatheter up over the whole thing to protect the partially deployed subject flow diverter that was halfway out.The physician removed it safely and successfully from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Event Description
It was reported that during the procedure, flow diverter (subject device) partially deployed but it did not detach completely.In order to refine the placement, the physician tried to insert the subject flow diverter into the microcatheter, but it could only be retracted halfway with no way to go further.The physician was forced to pull the carrier microcatheter up over the whole thing to protect the partially deployed subject flow diverter that was halfway out.The physician removed it safely and successfully from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available.Therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.It was reported that the subject flow diverter partially deployed during the procedure.In order to refine the placement, the physician tried to resheath the flow diverter into the microcatheter but it could only be retracted halfway.The physician had to pull the carrier catheter over the flow diverter in order to protect it and safely extract it from the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
 
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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 Key12376204
MDR Text Key268448625
Report Number3008881809-2021-00349
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 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/12/2022
Device Catalogue NumberFD45020
Device Lot Number21862561R
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN MICROCATHETER.; UNKNOWN MICROCATHETER
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