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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 30MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 30MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS45030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Ischemia Stroke (4418); Embolism/Embolus (4438)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that the subject flow diverter was deployed across the neck of the unruptured posterior communicating artery aneurysm and there was narrowing at the mid-section of the subject device following deployment. Physician determined that the patient had underlying intracranial atherosclerotic disease in this portion of the internal carotid artery. During procedure, the physician tried to treat the device narrowing using a balloon but was not successful. Patient had embolic showers and some stroke like symptoms, six hours post implantation of the subject flow diverter. Unknown medication was given to the patient. Patient condition was stable. No other information is available.
 
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Brand NameSURPASS EVOLVE 4.5MM X 30MM - 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 Key10659866
MDR Text Key211282077
Report Number3008881809-2020-00296
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFDS45030
Device Catalogue NumberFDS45030
Device Lot Number22240834
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 Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/09/2020 Patient Sequence Number: 1
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