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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS40150
Device Problem Activation Failure (3270)
Patient Problems Stroke/CVA (1770); Dysphasia (2195)
Event Date 04/26/2022
Event Type  Injury  
Event Description
It was reported that the proximal stent (subject device) didn't open.Could not get through it again and had to use evo stent as a medical intervention to plaster the stent (subject device) against the carotid wall.The patient is experiencing some word-finding difficulties postoperatively, possibly a small embolic stroke.There was a surgical delay.The procedure did not complete successfully.No other information was provided.
 
Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 device was not returned as it was implanted.It cannot be confirmed if the device met specification, as the device was not returned.It was reported that the proximal stent did not open and get through it again, medical intervention was required to prevent permanent impairment, by deploying an evo stent to expand the proximal end of the stent to oppose the vessel wall.The patient experiencing some word finding difficulties post operatively, possibly a small embolic stroke as per the physician.The device was not returned for analysis as it had been implanted, therefore analysis was unable to be performed on the device.Based on the stent design and material properties, it is intended that the deployed stent will expand to its intended size, this can however be compromised if damage is sustained to the stent at any stage during use, as the stent was not returned it cannot be determined if the stent sustained any damage, therefore an assignable cause of undeterminable will be assigned to the reported ¿stent failed/unable to open¿.The reportable ¿patient neurological deficit¿ and ¿patient stroke¿ are listed in the atlas stent dfu as anticipated outcomes of these types of procedures.It cannot be determined from the available information if the failure of the proximal end of the atlas stent to open may have caused or contributed to the patient stroke or neurological deficit, therefore an assignable cause of anticipated procedural complication, will be assigned to the reported ¿patient neurological deficit¿ and ¿patient stroke¿.
 
Event Description
It was reported that the proximal stent (subject device) didn't open.Could not get through it again and had to use evo stent as a medical intervention to plaster the stent (subject device) against the carotid wall.The patient is experiencing some word-finding difficulties postoperatively, possibly a small embolic stroke.There was a surgical delay.The procedure did not complete successfully.No other information was provided.
 
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Brand Name
NEUROFORM ATLAS 4.0MM 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
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI   NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key14379966
MDR Text Key294651468
Report Number3008881809-2022-00221
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P180031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue NumberM003EZAS40150
Device Lot Number20162776
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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