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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 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003SZAS45210
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
Event Type  malfunction  
Event Description
It was reported that after transferring the stent (subject device) into the microcatheter and while advancing the stent, only the delivery wire protruded out of the microcatheter tip and the stent had prematurely deployed during use and remained stuck inside the microcatheter.The physician replaced it with new devices and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the stent was returned inside the microcatheter with an additional stent.The stent delivery wire was kinked/bent.The stent was deformed.No other anomalies were noted.Functional testing could not be performed due to the condition of the returned device.Based on device analysis, it is likely that the stent delivery wire slipped through the stent due to the presence of the second stent in the microcatheter.The damage noted to the stent delivery wire and stent is also likely to have been due to the presence of the second stent.Therefore, an assignable cause of procedural factors will be assigned to this investigation.
 
Event Description
It was reported that after transferring the stent (subject device) into the microcatheter and while advancing the stent, only the delivery wire protruded out of the microcatheter tip and the stent had prematurely deployed during use and remained stuck inside the microcatheter.The physician replaced it with new devices and continued the procedure without clinical consequences to the patient.
 
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Brand Name
NEUROFORM ATLAS STENT SYSTEM 4.5 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 Key8782790
MDR Text Key150830776
Report Number3008881809-2019-00199
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
P180031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/03/2019
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 Date12/15/2023
Device Catalogue NumberM003SZAS45210
Device Lot Number21103647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/11/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 MICROCATHETER (STRYKER)
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