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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 15MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 15MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS45150
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2018
Event Type  malfunction  
Event Description
It was reported that during advancement of the stent within the microcatheter, there was strong resistance 20 to 30 cm from the hub and the stent could not be moved further.When removing the stent, the stent prematurely detached from the delivery wire and the stent remained within the microcatheter.There were no clinical consequences to the patient.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.An sl-10 microcatheter was returned with the subject stent within.During functional test, the sl-10 microcatheter was flushed without difficulty.A patency mandrel was advanced through the microcatheter from the distal end and the subject stent deployed in the hub without difficulty.There was some slight deformation noted to the stent.There are numerous procedural factors which may have caused the as reported event from stent transfer to stent advancement through the microcatheter.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to this investigation.
 
Event Description
It was reported that during advancement of the stent within the microcatheter, there was strong resistance 20 to 30 cm from the hub and the stent could not be moved further.When removing the stent, the stent prematurely detached from the delivery wire and the stent remained within the microcatheter.There were no clinical consequences to the patient.
 
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Brand Name
NEUROFORM ATLAS STENT SYSTEM 4.5 X 15MM WITHOUT TIP
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8246707
MDR Text Key133048481
Report Number3008881809-2019-00026
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H020002/S046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Catalogue NumberM003EZAS45150
Device Lot Number19779305
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Initial Date Manufacturer Received 12/19/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received02/25/2019
Supplement Dates FDA Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
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