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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X30 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 5X30 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003121FPP0
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
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 stabilizer and the catheter were found disassembled and the flow diverter was deployed. The stabilizer was extensively stretched at 60 cm from the distal end. The delivery catheter was flat/crushed at 13 cm from the distal end. Functional testing could not be performed since the flow diverter was already found deployed and the components were disassembled. As per the additional information provided, the patient¿s anatomy was very tortuous. The device was returned and the damage to the device was indicative of the as reported event. It is probable that the device was damage during the clinical procedure because of a very tortuous anatomy, causing the as reported event. An assignable cause of procedural factors was assigned to the as reported issue 'nv - stent delivery catheter/ guide catheter friction' and to the as analyzed issues ' nv ¿ stent deployed prematurely outside patient', ' nv ¿ stent stabilizer deformed ', and ' nv ¿ stent delivery catheter flat/ crushed ', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the 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 found that the flow diverter (subject device) had been deployed. There was clinical consequences to the patient as a result of this event.
 
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Brand NameSURPASS 5X30
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 Key7993460
MDR Text Key124672195
Report Number3008881809-2018-00459
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKR
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 10/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberM003121FPP0
Device Lot Number19880942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2017
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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