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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003SFD040250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Event Date 02/13/2019
Event Type  Death  
Manufacturer Narrative
This is 1 of 8 reports. The device is not available to the manufacturer.
 
Event Description
It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device). There were procedure related complications reported in 12 patients and an event of death was reported on two patients, this report addresses the mortality event relating to the first patient. No further information is available.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 25MM - PMA
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 Key9967991
MDR Text Key187904579
Report Number3008881809-2020-00105
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/25/2019
Device Catalogue NumberM003SFD040250
Device Lot Number21049977
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 Received07/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2018
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: 04/16/2020 Patient Sequence Number: 1
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