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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E45200
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2019
Event Type  malfunction  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during procedure the stent (subject device) was difficult to advance within the microcatheter.The stent prematurely deployed within the microcatheter during retrieval.There were no clinical consequences to the patient.
 
Event Description
It was reported that during procedure the stent (subject device) was difficult to advance within the microcatheter.The stent prematurely deployed within the microcatheter during retrieval.There were no clinical consequences to the patient.
 
Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the stent had been deployed and deformed, the distal tip of the introducer sheath was damaged and the stent delivery wire sdw was kinked.It is probable that the introducer sheath was damaged during insertion into the hub of the microcatheter causing damage to the stent and the subsequent difficulty to advance through the microcatheter.An assignable cause of procedural factors will be assigned to the investigation as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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Brand Name
NEUROFORM 3 EZ- 4.5 X 20MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8872315
MDR Text Key153674773
Report Number3008881809-2019-00233
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H020002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/26/2021
Device Catalogue NumberM003EN3E45200
Device Lot Number20697346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Date Manufacturer Received10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XT-27 MICROCATHETER (STRYKER)
Patient Age80 YR
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