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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS40210
Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2024
Event Type  Injury  
Event Description
It was reported that during right posterior communicating artery (pcoma) wide-necked aneurysm procedure, the operator used the guidewire to bring the microcatheter to right middle cerebral artery (mca).Next, the operator used the guidewire to bring another catheter to posterior communicating artery (pcoma) aneurysm lumen.The operator inserted a coil and because it was not stable the subject stent was deployed and fully expanded in the vessel.Next, the operator withdrew the delivery wire and the subject stent migrated suddenly.Under digital subtraction angiography (dsa) it could be seen that the distal marker of the subject stent went into lumen of the aneurysm.As a medical intervention the operator deployed another stent and filled several coils to press the subject stent and successfully completed the procedure.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
H3 other text : the device remains implanted in the patient.
 
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.F10 / h6 medical device problem code - device code grid - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was returned.The stent delivery wire (sdw) was found to be kinked/bent 17cm and 48cm from the distal end.There was a kink noted at the proximal side of the proximal bumper.The stent was not returned for analysis.The stent introducer sheath was not returned for analysis.Functional inspection was not performed as the stent was not returned for analysis.The reported event is covered in the device direction 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 events 'stent dislodged/migrated' and 'sdw stuck in stent' were undeterminable as the stent was not returned for analysis.The stent delivery wire (sdw), which was the only part of the device returned, did not meet specifications when received for complaint investigation based on visual inspection.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was described as 'moderately tortuous'.It was reported that the operator 'prepared to deploy a stent with the microcatheter.After placing the subject stent to the location, the operator deployed the stent and after it was fully expanded in vessel the operator withdrew the delivery wire.However, during this procedure, the stent migrated suddenly and under digital subtraction angiography (dsa) it could be seen that the distal marker of the stent went into lumen of aneurysm.So, the operator placed the microcatheter again and deployed another stent to deploy and filled several coils to press the first stent and finished the procedure'.The stent was not returned as it had been deployed inside the patient.The introducer sheath was also not returned for analysis.The sdw was the only part of the atlas system that was returned for analysis.The sdw was kinked/bent in several locations along its length.The reported events: ¿stent dislodged/migrated' and 'sdw stuck in stent' will be assigned undeterminable as the stent was deployed in the patient and was not available for analysis.The analyzed event: ¿sdw kinked/bent¿ will be assigned procedural factors 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 and/or anatomical factors during use.
 
Event Description
It was reported that during right posterior communicating artery (pcoma) wide-necked aneurysm procedure, the operator used the guidewire to bring the microcatheter to right middle cerebral artery (mca).Next, the operator used the guidewire to bring another catheter to posterior communicating artery (pcoma) aneurysm lumen.The operator inserted a coil and because it was not stable the subject stent was deployed and fully expanded in the vessel.Next, the operator withdrew the delivery wire and the subject stent migrated suddenly.Under digital subtraction angiography (dsa) it could be seen that the distal marker of the subject stent went into lumen of the aneurysm.As a medical intervention the operator deployed another stent and filled several coils to press the subject stent and successfully completed the procedure.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
NEUROFORM ATLAS 4.0MM 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
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 Key18602508
MDR Text Key334025651
Report Number3008881809-2024-00036
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 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EZAS40210
Device Lot Number24349375
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2023
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
AXIUM APB-3-8 COIL (MEDTRONIC); ECHELON 10 CATHETER (MEDTRONIC); SYNCHRO 14 GUIDEWIRE (STRYKER); XT-17 MICROCATHETER (STRYKER)
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient SexFemale
Patient Weight60 KG
Patient RaceAsian
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