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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS45210
Device Problems Premature Activation (1484); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that during the procedure, when the physician attempted to deploy the stent (subject device), it was not present in the shaft.The subject stent had prematurely detached during use.The procedure was not completed successfully as the physician was not able to place the subject stent inside the patient's anatomy.No clinical consequences were reported to the patient due to this event.No further information is available at the moment.
 
Manufacturer Narrative
B5 - executive summary: updated d4 expiration date - added h4 manufacturing date ¿ added due to the automated controls within the mes system it is not possible for the edhr of released product built using mes to contain any discrepancies that could have contributed to the reported event.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed and it cannot be determined that the device met specification upon release, as the device was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as analysed event.In the case of this complaint it is likely that the stent was deployed prematurely during unpacking of the device or during preparation, this however cannot be conclusively determined.During device manufacture components are electronically scanned to ensure the component is present as per nv00021039.In addition confirmation the stent is loaded is verified as per procedure nv00004165.While there are a number of potential causes for the reported issue, as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause, an assignable cause of undeterminable will be assigned to this complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
Event Description
It was reported that during the procedure, when the physician attempted to deploy the stent (subject device), it was not present in the shaft.The subject stent had prematurely detached during use.The procedure was not completed successfully as the physician was not able to place the subject stent inside the patient's anatomy.No clinical consequences were reported to the patient due to this event.No further information is available at the moment.Update: based on further review of the event on 14-jul-2020, the stent was missing from the shaft but did not deploy prematurely during the procedure inside the patient anatomy.
 
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Brand Name
NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key10084284
MDR Text Key192250700
Report Number3008881809-2020-00157
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 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/05/2024
Device Catalogue NumberM003EZAS45210
Device Lot Number21361900
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 MICROCATHETER (STRYKER)
Patient Age44 YR
Patient Weight64
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