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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
The subject device remains implanted.
 
Event Description
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica). The patient had severely tortuous anatomy. A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully. On the final angiography run, it was noticed that the distal vessel had a slow flow. A computed tomography (ct) scan was performed but the images were not clear. Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature. The physician applied a little glue to treat the ruptured vessel. No other information was provided.
 
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Brand NameUNKNOWN (SURPASS STREAMLINE)
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8745594
MDR Text Key149554995
Report Number3008881809-2019-00187
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/24/2020
Device Catalogue NumberFD40020
Device Lot Number21323883
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 Received11/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/28/2019 Patient Sequence Number: 1
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