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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 UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 12/10/2019
Event Type  Injury  
Manufacturer Narrative
The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa. The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024). See section 4. 11. 3 guidance for industry and food and drug administration staff, november 8, 2016. The device remains implanted in the patient.
 
Event Description
It was reported that a patient had their para ophthalmic aneurysm treated with the stent flow diverter (subject device) on (b)(6) 2019 and approximately two weeks later, the patient was presented with a minor narrowing(40 -50%) of their supraclinoid ica just distal to the distal edge of the stent flow diverter. The cause of the narrowing of the vessel was not confirmed and may or may not be attributed to the implant. A secondary procedure was performed to extend the stent distally with another stent (non-stryker stent) and post angioplasty. The angiographic result showed that the narrowing had been fixed, and the patient has recovered well. The patient was reported to be in good condition. No further information is available.
 
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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
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 Key9533596
MDR Text Key176098997
Report Number3008881809-2019-00415
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAU
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_NEU
Device Lot Number21570416
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 Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/30/2019 Patient Sequence Number: 1
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