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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 20MM - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 20MM - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number M003SFD040200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
This is the 14th of 14 reports. Subject device remains implanted.
 
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. One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm 8 x 5 mm (aneurysm size 5-9. 9 mm) on the right posterior communicating artery recurrently stented with non-stryker coils and non-stryker stent. There was minor complication of left facial droop and left wrist weakness immediately post procedure. There was no definitive stent-associated thrombus causing neurological symptoms on repeat angiography. The patient was treated with intraarterial intracatheter intracerebral integrillin 1 mg and tissue plasminogen activator (tpa) 2 mg in event microembolism would be present. Persistent facial numbness following repeat angiogram/thrombolysis. 1 month later, persistent filling of aneurysm measuring 12 x 7 mm on aagnetic resonance angiography (mra).
 
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Brand NameSURPASS STREAMLINE 4.0MM X 20MM - 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 Key10103968
MDR Text Key193661446
Report Number3008881809-2020-00163
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
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/23/2020
Device Model NumberM003SFD040200
Device Catalogue NumberM003SFD040200
Device Lot Number21551508
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 Manufactured06/25/2019
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: 05/31/2020 Patient Sequence Number: 1
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