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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 3.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 3.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003102FPP0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 10/23/2015
Event Type  Injury  
Manufacturer Narrative
A review of the device history record confirmed that the device met all material, assembly and performance specifications. The device was not returned, therefore physical as well as function analysis of the device was not performed. The reported patient parent vessel stenosis is a known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use. Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported event. The subject device remains implanted inside patient.
 
Event Description
Based on the core lab review of the imaging 6 months post procedure, 100% parent vessel stenosis was noted. Dual antiplatelet therapy is required as the treatment. No malfunction or adverse event has been reported from the site. No further information is available.
 
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Brand NameSURPASS STREAMLINE 3.0MM X 25MM - 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 Key10005880
MDR Text Key189632059
Report Number3008881809-2020-00121
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2015
Device Catalogue NumberM003102FPP0
Device Lot Number108024867
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 Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2014
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: 04/28/2020 Patient Sequence Number: 1
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