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

Catalog Number M003EZAS30210

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm procedure, the operator used the microcatheter to deliver the subject stent to a2 distal and deployed it.However, the tension of the microcatheter was too big during the subject stent deployment.The tip of the microcatheter migrated from distal of the aneurysm to proximal and the distal marker of the subject stent went out from the microcatheter.The operator then withdrew the microcatheter together with the subject stent and it deployed in the y-valve.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm procedure, the operator used the microcatheter to deliver the subject stent to a2 distal and deployed it.However, the tension of the microcatheter was too big during the subject stent deployment.The tip of the microcatheter migrated from distal of the aneurysm to proximal and the distal marker of the subject stent went out from the microcatheter.The operator then withdrew the microcatheter together with the subject stent and it deployed in the y-valve.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

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.During visual inspection the stent was found to be deployed.The distal part of the stent was found to be deformed.The distal part of the stent delivery wire (sdw) was found to be bent.The stent introducer sheath was found to be intact.Functional inspection to test the reported events: stent partial deployment and stent friction was not performed as the stent was found to be deployed.Functional inspection to test the reported events: stent deployed prematurely during retraction/re-sheathing was not performed as the issue was confirmed during visual inspection.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 partial deployment, stent friction, device interaction with another device could not be duplicated; however, the analysis results are consistent with the reported events.The reported stent deployed prematurely during retraction/re-sheathing was confirmed during the analysis.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that used stent to assist.Placed the microcatheter to deliver the subject stent to a2 distal and deployed it.However, the tension of the microcatheter was too big during stent deployment the tip of the microcatheter migrated from distal of aneurysm to proximal and the distal marker of the stent went out from microcatheter.The operator then withdrew the microcatheter and the stent was then deployed in y valve.Additional information provided by the physician indicates that the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The device was returned and it was confirmed that the stent had been prematurely deployed, the stent delivery wire (sdw) was kinked and the stent was deformed.It is probable that the difficulty to withdraw the microcatheter during the deployment attempt may have been due to anatomical/procedural factors present during use, this is likely to have caused the sudden movement of the microcatheter and subsequent partial stent deployment from the distal end of the microcatheter.It is probable that the partially deployed stent then fully deployed in the rotating hemostatic valve (rhv) when removed along with the microcatheter.An assignable cause of procedural factors will be assigned to the reported events ¿stent deployed prematurely during retraction/re-sheathing¿, ¿device interaction with another device¿, ¿stent partial deployment¿ and ¿stent friction¿ and to the analyzed events: ¿stent deployed prematurely during retraction/re-sheathing¿, ¿sdw kinked/bent¿, ¿stent deformed¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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: 18905990
• MDR Text Key: 337704732
• Report Number: 3008881809-2024-00106
• 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: 05/06/2024

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 Number: M003EZAS30210
• Device Lot Number: 24398517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: SYNCHRO (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: Asian