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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 FD32517
Device Problem Difficult or Delayed Activation (2577)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2019
Event Type  malfunction  
Manufacturer Narrative
Catalog#: unknown, lot/serial no. : unknown. The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. During the analysis of the returned device, it was revealed that the stent was partially deployed and deformed. During the functioning test, the stent was unable to be retracted into the microcatheter due to the solidified contrast media. As per the additional information, the subject device was in good condition prior to use and the patient¿s anatomy was type ii tortuous. A probable cause of procedural factors will be assigned to the reported event and analyzed defects, as the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited. The neurovascular stryker surpass evolve device is currently not 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.
 
Event Description
During the analysis of the returned device, it was revealed that the stent was partially deployed. No clinical consequences reported to the patient.
 
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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
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 Key9474039
MDR Text Key176102839
Report Number3008881809-2019-00391
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
P170024/S003
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 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2020
Device Catalogue NumberFD32517
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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