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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003SZAS30210
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during advancement of the stent (subject device) through a microcatheter, the stent prematurely disconnected from the delivery wire within the microcatheter.The stent and microcatheter were removed as one unit.There were no clinical consequences to the patient.
 
Event Description
It was reported that during advancement of the stent (subject device) through a microcatheter, the stent prematurely disconnected from the delivery wire within the microcatheter.The stent and microcatheter were removed as one unit.There were no clinical consequences to the patient.
 
Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Information available indicated that the device was confirmed to be in good condition prior to use.It is probable that there were some procedural/anatomical factors that contributed to the event; this however cannot be conclusively determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
 
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Brand Name
NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8567575
MDR Text Key143678032
Report Number3008881809-2019-00114
Device Sequence Number1
Product Code NJE
UDI-Device Identifier07613252656159
UDI-Public07613252656159
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 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2023
Device Catalogue NumberM003SZAS30210
Device Lot Number21069100
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XT-17 MICROCATHETER (STRYKER)
Patient Age52 YR
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