MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS30240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the subject device is implanted inside the patient's vasculature.

Event Description

It was reported that, during a neurovascular procedure, the subject stent was deployed in the anterior communicating artery.The physician thought the subject stent may have had its cells open up beyond the normal range around an acute tortuosity.He was unsure if that was the case as there was no definitive imaging or other proof to validate this thought.Due to this event patient was give integrilin intra-procedure to treat thrombus formation.No further information is available.

Event Description

It was reported that, during a neurovascular procedure, the subject stent was deployed in the anterior communicating artery.The physician thought the subject stent may have had its cells open up beyond the normal range around an acute tortuosity.He was unsure if that was the case as there was no definitive imaging or other proof to validate this thought.Due to this event patient was give integrilin intra-procedure to treat thrombus formation.No further information is available.

Manufacturer Narrative

Although the dhr (device history review) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device 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.As the product was not returned and review and analysis of all 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 event "stent deformed, patient vessel thrombosis".

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA
• 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: 16958344
• MDR Text Key: 315528416
• Report Number: 3008881809-2023-00260
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention