MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45210

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2022

Event Type  malfunction  

Event Description

It was reported that during the wide-neck aneurysm procedure, physician used a guidewire to bring the microcatheter to the target lesion.He prepared and inserted the subject stent to go through the microcatheter.The subject stent deployed prematurely inside the microcatheter shaft.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

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 swd (stent delivery wire ) was found to be kinked.The stent was removed from the the catheter shaft, the stent was deformed.The stent introducer sheath was found to be intact.Functional testing was unable to be performed as the stent was deployed in the concurrent catheter shaft.The stent could not be advanced in the concurrent catheter, the catheter shaft was cut in order to remove the stent.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 complaint was confirmed based on analysis and event description.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The sdw (stent delivery wire) was kinked.The stent was detached and was stuck within the concurrent catheter shaft.The stent was removed from the shaft and was found to be deformed.Based on the event description and the analysis the as reported can be confirmed.The as reported 'stent difficult/unable to advance or pullback through catheter' and 'stent deployed prematurely during use' as well as the as analyzed 'sdw kinked/bent¿ , 'stent deployed prematurely during use' & 'stent deformed' will be assigned procedural factors as this complaint appears to be associated with a product that met stryker and 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 wide-neck aneurysm procedure, physician used a guidewire to bring the microcatheter to the target lesion.He prepared and inserted the subject stent to go through the microcatheter.The subject stent deployed prematurely inside the microcatheter shaft.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM NO TIP - 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 Key: 16070547
• MDR Text Key: 307108786
• Report Number: 3008881809-2022-00658
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 23604190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENCHLON-10 MICROCATHETER (MEDTRONIC); EXCELSIOR SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); UNKNOWN COIL
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Asian