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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 Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that the subject flow diverter had fishmouthing and distal tapering which was observed during one year follow up angiography. There was also slight intimal hyperplasia at distal stent. Physician reported that the case went smoothly with no difficulties. Immediate post implant fluoroscopy images showed good wall apposition to internal carotid artery (ica). Physician is unable to determine leading cause of event. Patient does not require recanalization due to vessel stenosis/ occlusion. Patient is reported to be clinically well and on standard anti-coagulation procedure. No further information is available.
 
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Brand NameSURPASS EVOLVE 4.5MM X 20MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10214581
MDR Text Key197163274
Report Number3008881809-2020-00186
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSG
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 09/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2020
Device Catalogue NumberFD45020
Device Lot Number21323878
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 Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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