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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 4 X 40 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK 4 X 40 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 113FPP
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2018
Event Type  malfunction  
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications. Analysis of the device reveled that the stent was partially deployed from the distal end of the catheter and the stabilizer was observed to be deformed. During functional testing, the catheter was flushed, blood was noted within the delivery catheter and on the deployed stent. The friction was experienced in advancing the stabilizer through the catheter. Blood within the delivery system is an indication of insufficient flush, however this cannot be definitively determined. It is probable that the blood within the delivery system caused the as reported difficulty to deploy the stent and the as analyzed defects. Therefore, an assignable cause of procedural factors will be assigned to the as reported event and analyzed anomalies, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use(dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
Analysis of the returned device revealed that the stent was partially deployed. There were no clinical consequences reported to the patient.
 
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Brand Name4 X 40 SURPASSTM SYSTEM
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 Key8241433
MDR Text Key132916897
Report Number3008881809-2019-00017
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number113FPP
Device Lot Number19383419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
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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