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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD45017
Device Problems Premature Activation (1484); Activation Failure (3270)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported that during the procedure for aneurysm treatment, the subject stent was advanced to the carotid siphon for deployment. The subject stent deployed prematurely inside the microcatheter and jumped in the patient's vessel. The proximal part of the deployed subject stent could not open in the vessel. The physician tried to remove the subject stent with a snare device but the attempt was not successful. The physician then decided to open the subject stent with a balloon, coming from the distal side of the subject stent (with an exchange length wire). The subject stent opened better after this attempt but the proximal part did not have a perfect opening and wall apposition. The physician deployed a new stent over the proximal side of the subject stent in order to completely open it and secure the wall apposition. A surgical delay of 1 hour 30 minutes was reported during the procedure. It was reported that there was formation of thrombus but it was dissolved. The patient's current condition was reported to be asymptotic. The procedure was completed successfully. No further information is available at the moment.
 
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Brand NameSURPASS EVOLVE 4.5MM X 17MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key11798971
MDR Text Key249803653
Report Number3008881809-2021-00193
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFD45017
Device Lot Number21785987R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
Treatment
NEUROFORM ATLAS STENT (STRYKER); UNKNOWN BALLOON CATHETER; UNKNOWN MICROCATHETER; UNKNOWN SNARE DEVICE
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