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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003SZAS40240C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The initial information indicates that the reported events are not related to the atlas stent and that the atlas was used successfully.It was determined by the cec that the adverse event was related to the stent.There was no allegation of any defect against the atlas.The treatment was carried out in response to coil compaction.The as reported events are known and anticipated complications to these types of procedures and patient condition, and are listed as such in the device dfu; therefore, an assignable cause classification of anticipated procedural complication will be assigned to this complaint.Based on the information currently available an assignable cause for this event cannot be determined.Subject devices remain implanted.
 
Event Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located at the basilar apex.Raymond scale post procedure was 1.It was reported that 12 month-post procedure, there was compaction of the aneurysm and endovascular re-intervention was required.According to the clinical events committee (cec),the aneurysm compaction was related to the procedure and to the subject device stent.
 
Event Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located at the basilar apex.Raymond scale post procedure was 1.It was reported that 12 month-post procedure, there was compaction of the aneurysm and endovascular re-intervention was required.According to the clinical events committee (cec),the aneurysm compaction was related to the procedure and to the subject device stent.Additional information received on 18-june-2021 reported that 281 days post procedure with the subject stent, the patient had a proximal stent stenosis that resolved with no residual effects without intervention and an acute ischemic stroke that was treated with unknown medication.No other information is available.
 
Manufacturer Narrative
B2 ¿ outcomes attributed to ae: updated.B5 ¿ executive summary: updated.B6 ¿ relevant tests and lab data: updated.F10/h6 ¿ clinical signs code grid, health impact code grid: updated.H6 ¿ results code, conclusion code: updated.H10 - additional mfg narrative: updated.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Based on the results of the dhr review, there is no indication that the device, labelling or packaging failed to meet its specifications when 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 direction for use (dfu) for this product covers patient in-stent stenosis and patient stroke as potential complication of a procedure.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 initial information indicates that the reported events are not related to the atlas stent and that the atlas was used successfully.It was determined by the cec that the adverse event was related to the stent.The coil compaction was assessed by the site to be coil related.The treatment was carried out in response to coil compaction.The as reported events are known and anticipated complications to these types of procedures and patient condition, and are listed as such in the device dfu, therefore an assignable cause classification of anticipated procedural complication will be assigned to this complaint.H3 other text : subject devices remain implanted.
 
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Brand Name
NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key8254787
MDR Text Key133279962
Report Number3008881809-2019-00029
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,study
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Catalogue NumberM003SZAS40240C
Device Lot Number19178493
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
4 TARGET COILS (STRYKER); 4 TARGET COILS (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age76 YR
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