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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS45040
Device Problem Activation Failure (3270)
Patient Problem Vasoconstriction (2126)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that during the procedure, the subject flow diverter was resheathed approximately seven times and the patient's internal carotid terminus vessel had vasospasm. The vessel vasospasm constricted the subject flow diverter and prevented it from opening which was realized after contrast injection. The physician administered verapamil and cardapine to treat the vasospasm which resolved. Then removed the device and replaced it with a second flow diverter which had a proximal twist/kink that was unable to be resolved with deployment. The second device was resheathed and removed form the patient anatomy. A third device was used and procedure was completed successfully. Patient was reported to be doing well.
 
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Brand NameSURPASS EVOLVE 4.5MM X 40MM - PMAS
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 Key10627894
MDR Text Key209840688
Report Number3008881809-2020-00283
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS45040
Device Catalogue NumberFDS45040
Device Lot Number22241194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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: 10/05/2020 Patient Sequence Number: 1
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