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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E40200
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that when the stent (subject device) was advanced into the microcatheter, the stent detached prematurely inside the tail of the microcatheter.The physician replaced it with a new stent and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the device found that the stent was returned in deployed state.The stent was deformed as well.No other anomalies were noted.Functional test could not be performed due to the condition of the returned device.Information available indicated that the device was confirmed to be in good condition prior to use and there is no indication of a use error.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the stent during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.
 
Event Description
It was reported that when the stent (subject device) was advanced into the microcatheter, the stent detached prematurely inside the tail of the microcatheter.The physician replaced it with a new stent and continued the procedure without clinical consequences to the patient.
 
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Brand Name
NEUROFORM 3 EZ- 4.0 X 20MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8303456
MDR Text Key134974533
Report Number3008881809-2019-00039
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H020002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue NumberM003EN3E40200
Device Lot Number20216493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Date Manufacturer Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GATEWAY BALLOON(STRYKER); XT 27 MICROCATHETER(STRYKER)
Patient Age72 YR
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