MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problem Activation Problem (4042)

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

Event Date 09/02/2022

Event Type  malfunction  

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 with a stryker catheter.The lot number was confirmed with the packaging label.During visual inspection the stent was seen to be partially deployed from the tip of the catheter.The stent delivery wire (sdw) was seen to be kinked and the stent was seen to be deformed.The introducer sheath was not returned.During the functional inspection the sdw was advanced to fully deploy the stent during analysis.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 stent failed/unable to deploy was confirmed based on the analysis.The reported stent difficult/unable to advance or pullback through catheter could not be confirmed; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analysed anomalies noted to the device.It was reported that after the stent reached the position, the operator withdrew the microcatheter to deploy it, and after 1.5 of tip was deployed, the stent got stuck at tip of microcatheter and could not be deployed completely.The operator tried to fix the stent delivery wire and pulled the microcatheter or the delivery wire to tried again but the stent was still not able to be deployed completely.The device was returned and the stent was note to be partially deployed from the distal end of the returned catheter, the sdw was kinked and the stent was deformed, the damage noted to the device is indicative of the reported events.It is probable that the stent was deformed during the attempt to deploy the stent causing the reported events.An assignable cause of procedural factors will be assigned to the reported stent difficult/unable to advance or pullback through catheter, stent failed/unable to deploy and to the analysed stent partial deployment, stent delivery wire kinked/bent and stent deformed, as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was, in general, used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

The device was returned for analysis and the investigation of the device revealed that the stent (subject device) was partially deployed.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM 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: 15909523
• MDR Text Key: 307833993
• Report Number: 3008881809-2022-00608
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 23265803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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: XT-17 MICROCATHETER (STRYKER)
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Asian