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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS30150
Device Problem Premature Activation (1484)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure for patient with aneurysm in the anterior communicating artery, embolization was planned with two stents to be placed in the y junction along with coils.The first stent was placed with difficulty due to tortuous anatomy.The subject stent was then attempted to be placed; however, a lot of resistance was felt within the microcatheter.Suddenly the resistance subsided, and it was observed on radiological control that the subject stent had prematurely deployed within the microcatheter.The procedure was postponed to another day.Patient status post procedure was asymptomatic.No additional information available.
 
Manufacturer Narrative
D4 expiration date - added h4 manufacturing date ¿ added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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 reported event.As per the available information the patient¿s anatomy was severely tortuous and as the second stent advanced, it presented a lot of resistance inside the microcatheter.It is probable that the tortuous nature of the patient¿s anatomy caused the reported resistance and subsequent premature stent deployment.An assignable cause of procedural factors will be assigned to this complaint as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
It was reported that during the procedure for patient with aneurysm in the anterior communicating artery, embolization was planned with two stents to be placed in the y junction along with coils.The first stent was placed with difficulty due to tortuous anatomy.The subject stent was then attempted to be placed; however, a lot of resistance was felt within the microcatheter.Suddenly the resistance subsided, and it was observed on radiological control that the subject stent had prematurely deployed within the microcatheter.The procedure was postponed to another day.Patient status post procedure was asymptomatic.No additional information available.
 
Event Description
It was reported that during the procedure for patient with aneurysm in the anterior communicating artery, embolization was planned with two stents to be placed in the y junction along with coils.The first stent was placed with difficulty due to tortuous anatomy.The subject stent was then attempted to be placed; however, a lot of resistance was felt within the microcatheter.Suddenly the resistance subsided, and it was observed on radiological control that the subject stent had prematurely deployed within the microcatheter.The procedure was postponed to another day.Patient status post procedure was asymptomatic.No additional information available.
 
Manufacturer Narrative
The device was returned within an sl-10 microcatheter.There was no packaging returned with the device, therefore the serial number cannot be confirmed.During visual inspection, no anomalies were noted to the returned deployed stent or the sl-10 microcatheter.During the functional inspection the returned sl-10 microcatheter was flushed and a patency mandrel was advanced from the distal end, as the patency mandrel was advanced from the distal end it pushed the stent, which was deployed within the microcatheter shaft, into the hub of the microcatheter.Once removed, there were no anomalies noted to the deployed stent, and the sl-10 microcatheter patency test then passed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.As per the available information the patients anatomy was severely tortuous and as the second stent advanced, it presented a lot of resistance inside the microcatheter.The stent was returned deployed within an sl-10 microcatheter, confirming the reported event.There were no anomalies noted to the deployed stent or to the returned sl-10 microcatheter.It is probable that the tortuous nature of the patients anatomy caused the reported resistance and subsequent premature stent deployment.An assignable cause of procedural factors will be assigned to the reported stent deployed prematurely during use and stent difficult unable to advance or pullback through catheter and analysed stent deployed prematurely during use, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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Brand Name
NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key10248705
MDR Text Key198337727
Report Number3008881809-2020-00199
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,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/09/2023
Device Catalogue NumberM003EZAS30150
Device Lot Number20864777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Date Manufacturer Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ALTAS STENT (STRYKER)
Patient Age64 YR
Patient Weight82
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