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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 5 X 20 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK 5 X 20 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 124FPP
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications. During visual inspection, the flow diverter was returned in its deployed state and was noted to be deformed. The delivery catheter was damaged at 2cm from the distal end and the stabilizer was kinked at 4cm from the distal end. The flow diverter was found deployed; therefore, a full functional testing could not be performed. The stabilizer was removed from the catheter without any difficulty. A patency test was performed on the catheter and friction was experienced at the location of the damage to the distal end. As per the additional information, there were no anomalies noted to the stent delivery system prior to use and the device was prepared as per direction for use (dfu). There was a 3-hour surgical delay; however, did not cause any serious injury to the patient. The patient¿s anatomy was very tortuous. It is probable that the severe tortuosity of the patient¿s anatomy caused the as reported difficulty to deploy the stent and the damage noted to the returned device. It is also probable that the flow diverter was deployed prematurely during removal of the device. An assignable cause of procedural factors was assigned to the as reported issue 'nv- stent failed/ unable to deploy' and the as analyzed issues 'nv- stent deployed prematurely outside patient', 'nv ¿ stent delivery catheter deformed', ' nv ¿ stent stabilizer kinked/ bent', 'nv ¿ stent deformed' and 'nv ¿ catheter friction', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
Analysis of the returned device found that the flow diverter had been deployed. There was clinical consequences to the patient as a result of this event.
 
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Brand Name5 X 20 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 Key7997412
MDR Text Key124823499
Report Number3008881809-2018-00465
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number124FPP
Device Lot Number19629692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2017
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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