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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Event Description
It was reported that during right mca (middle cerebral artery) m1 bifuration wide-necked aneurysm.The operator used the stent (subject device) to assist.Prepared and delivered it to go into the microcatheter, and when it reached distal of microcatheter, the stent (subject device) deployed from the delivery wire.The operator pushed the delivery wire but could not deploy the stent (subject device).The operator then withdrew the microcatheter and stent (subject device) out together.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was found to be deployed and not returned.Only stent introducer sheath and hoop were returned.The stent introducer sheath was found to be intact.A functional test was not performed as the reported event was confirmed during visual inspection.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 the analysis results.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'moderately torturous'.The device was analyzed.The stent was fund to be deployed and not returned.The sdw (stent delivery wire) was not returned.The stent introducer sheath was found to be intact.It is probable that the moderately tortuous anatomy may have caused friction and the reported issue.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'stent deployed prematurely during use' as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
 
Event Description
It was reported that during right mca (middle cerebral artery) m1 bifuration wide-necked aneurysm.The operator used the stent (subject device) to assist.Prepared and delivered it to go into the microcatheter, and when it reached distal of microcatheter, the stent (subject device) deployed from the delivery wire.The operator pushed the delivery wire but could not deploy the stent (subject device).The operator then withdrew the microcatheter and stent (subject device) out together.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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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
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 Key18327694
MDR Text Key330506703
Report Number3008881809-2023-00584
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
Reporter Country CodeCH
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 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EZAS30150
Device Lot Number24298865
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ECHELON-10 CATHETER (NON-STRYKER).
Patient Age78 YR
Patient SexMale
Patient RaceAsian
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