MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

Device Problem Component Missing (2306)

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that during right mca (middle cerebral artery) bifuration huge aneurysm case ,after delivered the stent (subject device) to near the location, the operator found the stent (subject device) marker not visible under fluoroscopy.The operator withdrew the stent (subject device) and replaced it with another one.The procedure was completed successfully.No clinical consequences were reported to the patent due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During a visual inspection, the stent was deployed from the sdw (stent delivery wire) and not returned, the sdw was seen to be kinked, and the introducer sheath was intact.A functional inspection was not carried out as the stent was not returned.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 could not be confirmed during analysis as the stent was not returned.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that after delivered the stent to near the location, the operator found no stent mark and the shape under fluoroscopy.Additional information states that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush set up and maintained throughout the clinical procedure and the patients anatomy was not tortuous.The same microcatheter was used successfully to to deliver and deploy a second stent.Only the introducer sheath and sdw (stent delivery wire) were returned, there was kinking noted to he distal tip of the sdw.The stent was not returned.As the same microcatheter was used to complete the procedure, it is likely that the stent was not prematurely deployed within the microcatheter during use.The physician was not able to find the stent.A material reconciliation was performed for the lot and there were no discrepancies found, indicating that all released product contained the stent.It is possible that the stent may have been prematurely deployed during removal from its packaging or during preparation of the device, and not detected, however this cannot be definitively determined.As the stent was not returned, and analysis of the returned device and the available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported 'ro marker detached/separated/not visible under fluoroscopy'.It is probable that the sdw was kinked during use during the clinical procedure, therefore an assignable cause of procedural factors will be assigned to the analyzed 'sdw kinked/bent'.

Event Description

It was reported that during right mca (middle cerebral artery) bifuration huge aneurysm case ,after delivered the stent (subject device) to near the location, the operator found the stent (subject device) marker not visible under fluoroscopy.The operator withdrew the stent (subject device) and replaced it with another one.The procedure was completed successfully.No clinical consequences were reported to the patent due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM 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: 15036083
• MDR Text Key: 303308617
• Report Number: 3008881809-2022-00351
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 23090151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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: 6F NAVI GUIDE CATHETER (NON - STRYKER); ANGIOGRAPHY CATHETER (NON - STRYKER); ECHELON-10 CATHETER (NON - STRYKER); GUIDEWIRE
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: Asian