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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 Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Stroke/CVA (1770); Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2019
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 stroke and patient serious headache are 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
It was reported that nineteen-month post procedure, the patient experienced ongoing right-sided headache which was not resolved with pain relief and the headache was along with strange sensation. In addition, the ct (computed tomography) imaging showed infarct. The symptom was resolved without sequelae with the treatment of in-patient hospitalization. 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
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 Key10059906
MDR Text Key191071466
Report Number3008881809-2020-00149
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,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2019
Device Catalogue NumberM003102FPP0
Device Lot Number19045927
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 Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2016
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: 05/14/2020 Patient Sequence Number: 1
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