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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS45300
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/25/2019
Event Type  Injury  
Event Description
It was reported that during procedure, the stent system was advanced to middle cerebral artery mca m1 distal part, the stent (subject device) was deployed from the internal carotid artery (ic) top.While the stent delivery catheter was pulled back with the stent tip part being slightly expanded, the stent system kicked back.When the physician advanced the microcatheter, the stent delivery wire, the microcatheter, and stent part became tangled.While trying to remove the delivery wire with force, the tip of the delivery wire broke and remained in patient.A new stent was deployed over the subject stent and broken delivery wire.The procedure was completed, and the patient was stable.
 
Manufacturer Narrative
Expiration date: updated.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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 stent itself was not returned but the stent delivery wire (sdw) was returned.During visual inspection, the device was inspected and the sdw was found kinked and damaged/ stretched/ broken.Functional inspection was not performed due to the damage.The reported defect was confirmed; the device failed to meet specifications when received for complaint investigation.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.In the case of this complaint the event was most likely due to some procedural/anatomical factors encountered during use.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to this complaint.
 
Event Description
It was reported that during procedure, the stent system was advanced to middle cerebral artery mca m1 distal part, the stent (subject device) was deployed from the internal carotid artery (ic) top.While the stent delivery catheter was pulled back with the stent tip part being slightly expanded, the stent system kicked back.When the physician advanced the microcatheter, the stent delivery wire, the microcatheter, and stent part became tangled.While trying to remove the delivery wire with force, the tip of the delivery wire broke and remained in patient.A new stent was deployed over the subject stent and broken delivery wire.The procedure was completed, and the patient was stable.
 
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Brand Name
NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM WITHOUT TIP
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9501125
MDR Text Key176097671
Report Number3008881809-2019-00403
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
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue NumberM003EZAS45300
Device Lot Number201103298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 MICROCATHETER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
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