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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E25150
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2018
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that when the stent (subject device) was being advanced and fixed onto to the tip of a microcatheter, there was difficulty in delivering the stent and it dislodged from its placed position.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.
 
Event Description
It was reported that when the stent (subject device) was being advanced and fixed onto to the tip of a microcatheter, there was difficulty in delivering the stent and it dislodged from its placed position.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.It was additionally reported and clarified that the stent (subject device) did not dislodge from its placed position, but had prematurely deployed outside the patient during removal from microcatheter hub.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
Additional information confirmed that the stent did not dislodge from its placed position.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.Therefore, the event no longer meets the requirement of the reportable event for the device in question.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
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Brand Name
NEUROFORM 3 EZ- 2.5 X 15MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8215520
MDR Text Key132061440
Report Number3008881809-2019-00006
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 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EN3E25150
Device Lot Number20457928
Was Device Available for Evaluation? No
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XT-27 MICROCATHETER(STRYKER)
Patient Age32 YR
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