Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E30200
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2023
Event Type  malfunction  
Event Description
It was reported that during the mca stenosis cases, the subject stent was delivered into the microcatheter.During delivery the subject stent got stuck at the proximal end of the microcatheter and could not be advanced forward or retracted back.The subject stent got fractured when it was pulled out of the subject 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) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was returned deployed and noted to be deformed.The sdw (stent delivery wire) was noted to be kinked/bent.The stent was noted to be broken/fractured.The sdw was noted to be broken/fractured.The introducer sheath distal tip was noted to be damaged.Functional inspection could not be performed as the stent was deployed.The reported event is covered in the device direction 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 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 stent broken/fractured during use was confirmed during the analysis.The device did not meet specifications when received for complaint investigation based on visual inspection.The device was analyzed.The stent was found to be deployed, broken/fractured and deformed.The sdw was found to be kinked/bent and broken/fractured.The tip of the stent introducer sheath was found to be damaged.The event description indicated that the subject stent was being used in a stenosis case which is not recommended.The subject stent dfu states "the stent system is intended to be used with occlusive devices in the treatment of intracranial aneurysms".An assignable cause of procedural factors will be assigned to the as reported stent difficult/unable to advance or pullback through catheter, as reported/as analyzed code stent broken/fractured during use, and to the as analyzed codes stent deployed prematurely during use, stent deformed, sdw broken/fractured during use, introducer sheath distal tip damaged and sdw kinked/bent as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
 
Event Description
It was reported that during the mca stenosis cases, the subject stent was delivered into the microcatheter.During delivery the subject stent got stuck at the proximal end of the microcatheter and could not be advanced forward or retracted back.The subject stent got fractured when it was pulled out of the subject microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEUROFORM 3 EZ 3.0MM X 20MM - 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 Key17475809
MDR Text Key320758241
Report Number3008881809-2023-00399
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,Followup
Report Date 09/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EN3E30200
Device Lot Number23538907
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2022
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
RUIKANGTONG MICROCATHETER (NON - STRYKER).
Patient Age57 YR
Patient SexMale
Patient Weight72 KG
Patient RaceAsian
-
-