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

Model Number M003UZAS30240

Device Problem Premature Activation (1484)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that the stent (subject device) prematurely partially deployed and was unable to be recaptured during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product 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.No additional information was received.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.

Event Description

It was reported that the stent (subject device) prematurely partially deployed and was unable to be recaptured during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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
• MDR Report Key: 11182639
• MDR Text Key: 227748109
• Report Number: 3008881809-2021-00032
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 21459508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other