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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 Problem Premature Activation (1484)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/15/2022
Event Type  Injury  
Event Description
It was reported that a stent assisted coiling procedure was performed in a patient with aneurysm in the communicating artery of ica (internal carotid artery).Initially the physician used a guidewire to bring one microcatheter to the left mca (middle cerebral artery) m2 segment and a second microcatheter to go into the aneurysm.Later the physician framed the coils and then prepared to deliver the subject stent.During the procedure the subject stent was advanced to the distal of microcatheter and, the microcatheter was retracted to release the tension and then placed in the location and prepared to deploy the subject stent.However, the subject stent was stuck at tip of microcatheter and could not be advanced out of microcatheter, therefore the physician decided to withdraw the subject stent along with the microcatheter.At this point in the procedure during retrieval of the subject stent along with the microcatheter, the tip of the subject stent deployed unexpectedly out of microcatheter.The subject stent was located in c5 segment and could not be withdrawn, so the physician deployed the subject stent in c5 segment of mca.The subject stent and the microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the stent was deployed from the sdw.The sdw was seen to be kinked.The stent or introducer sheath were not returned.Functional inspection: not carried out as the stent was deployed and 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.The reported complaint codes 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.Addition information received indicated 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.The patients anatomy was described as 'moderately tortuous' which may have been a contributing factor to the event.It was reported that 'after advanced the stent to distal of microcrater, retracted to release the tension and then placed it to the location and prepared to deploy.However the stent was stuck at tip of microcatheter and could not be advanced out of microcatheter.The operator decided to withdraw the stent with the microcatheter but when retracting them to c5, tip of the stent deployed unexpectedly out of microcatheter.It was located in c5 and could not be withdrawn.So the operator had to deploy the stent at the place and used another microcatheter and another stent to finish the procedure'.The stent was not returned for analysis as it had been deployed in the patient per the event description.The introducer sheath was also not returned for analysis.The sdw was returned and was noted to be kinked/bent.The as reported (ar) code 'stent deployed prematurely during use' will be assigned procedural factors and the ar code 'stent failed/unable to deploy' will be assigned undeterminable as the stent was deployed in the patient and was not available for analysis.The as analyzed '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 a stent assisted coiling procedure was performed in a patient with aneurysm in the communicating artery of ica (internal carotid artery).Initially the physician used a guidewire to bring one microcatheter to the left mca (middle cerebral artery) m2 segment and a second microcatheter to go into the aneurysm.Later the physician framed the coils and then prepared to deliver the subject stent.During the procedure the subject stent was advanced to the distal of microcatheter and, the microcatheter was retracted to release the tension and then placed in the location and prepared to deploy the subject stent.However, the subject stent was stuck at tip of microcatheter and could not be advanced out of microcatheter, therefore the physician decided to withdraw the subject stent along with the microcatheter.At this point in the procedure during retrieval of the subject stent along with the microcatheter, the tip of the subject stent deployed unexpectedly out of microcatheter.The subject stent was located in c5 segment and could not be withdrawn, so the physician deployed the subject stent in c5 segment of mca.The subject stent and the microcatheter were replaced and the procedure was completed successfully.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 Key13771844
MDR Text Key287204872
Report Number3008881809-2022-00120
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 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EZAS40210
Device Lot Number23125024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2021
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
EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
Patient Outcome(s) Required Intervention; Other;
Patient Age66 YR
Patient SexMale
Patient RaceAsian
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