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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E30150
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2023
Event Type  malfunction  
Event Description
It was reported that during the mca (middle cerebral artery) stenosis procedure, it was reported the stent (subject device) was stuck in the microcatheter during delivery.Following this the stent (subject device) deployed prematurely in the proximal tail of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the device was returned with the microcatheter.The stent was found to be deployed inside the hub.The stent was found to be intact.The sdw (stent delivery wire) and the stent introducer sheath were not returned.Functional testing was not completed due to device condition.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 event of stent difficult/unable to advance or pullback through catheter could not be duplicated; however, the analysis results are consistent with the reported event.The reported event of stent deployed prematurely during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'moderately torturous'.The device was returned for analysis.The returned stent was found to be deployed inside the hub and it was found to be intact.The sdw and stent introducer sheath were not returned.An assignable cause of procedural factors will be assigned to the as reported event of stent difficult/unable to advance or pullback through catheter and to the as analyzed event of stent deployed prematurely during retraction/re-sheathing as this complaint appears to be associated with a product that met stryker design and manufacturing specifications , but performance was limited due to procedural and/or anatomical factors during use.An assignable code of not confirmed will be assigned to the as reported event of stent deployed prematurely during use as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
Event Description
It was reported that during the mca (middle cerebral artery) stenosis procedure, it was reported the stent (subject device) was stuck in the microcatheter during delivery.Following this the stent (subject device) deployed prematurely in the proximal tail of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
NEUROFORM 3 EZ 3.0MM X 15MM - 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 Key18584600
MDR Text Key333824999
Report Number3008881809-2024-00030
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
H020002/S046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2024
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 Catalogue NumberM003EN3E30150
Device Lot Number23528668
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2024
Initial Date FDA Received01/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2022
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
XT-27 MICROCATHETER (STRYKER)
Patient Age62 YR
Patient SexMale
Patient Weight80 KG
Patient RaceAsian
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