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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 Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2018
Event Type  malfunction  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during procedure the stent (subject device) could not be advanced within the microcatheter.The operator tried to withdraw the stent and found the stent already deployed within microcatheter.There were no clinical consequences to the patient.
 
Manufacturer Narrative
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 stent was deployed when received for analysis.Visual examination of the returned device revealed that the stent delivery wire was kinked, and the stent was deformed.No anomalies were noted to the device prior to use and there is no indication of a use error.The stent was noted to be damaged when returned for analysis.It is likely that the stent deformed during the procedure causing the reported event.An assignable cause of procedural factors will be assigned to this investigation.
 
Event Description
It was reported that during procedure the stent (subject device) could not be advanced within the microcatheter.The operator tried to withdraw the stent and found the stent already deployed within microcatheter.There were no clinical consequences to the patient.
 
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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 Key8245146
MDR Text Key132981331
Report Number3008881809-2019-00024
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 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number20697370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received02/08/2019
Supplement Dates FDA Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR XT-27 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
Patient Age66 YR
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