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

Model Number M003UZAS30240

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Neurological Deficit/Dysfunction (1982); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that during a stent-assisted coiling with the subject stent for an aneurysm located in the right middle cerebral, at main branching (trifurcation) , the patient experienced sensitive deficit in the left inferior limb and motor deficit in the left superior limb.There was suspicion of micro-clot.Spontaneously resolved without sequelae 2 days post-procedure.According to the physician, the adverse event of neurological deficit is non-serious, and it is unknown if the adverse event is related to the subject device or the index procedure.Additional information has been requested.

Manufacturer Narrative

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.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 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.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

Event Description

It was reported that during a stent-assisted coiling with the subject stent for an aneurysm located in the right middle cerebral, at main branching (trifurcation) , the patient experienced sensitive deficit in the left inferior limb and motor deficit in the left superior limb.There was suspicion of micro-clot.Spontaneously resolved without sequelae 2 days post-procedure.According to the physician, the adverse event of neurological deficit is non-serious, and it is unknown if the adverse event is related to the subject device or the index procedure.Additional information has been requested.

Event Description

It was reported that during a stent-assisted coiling with the subject stent for an aneurysm located in the right middle cerebral, at main branching (trifurcation) , the patient experienced sensitive deficit in the left inferior limb and motor deficit in the left superior limb.There was suspicion of micro-clot.Spontaneously resolved without sequelae 2 days post-procedure.According to the physician, the adverse event of neurological deficit is non-serious, and it is unknown if the adverse event is related to the subject device or the index procedure.Additional information has been requested.

Manufacturer Narrative

The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.H3 : subject device remains implanted.

• 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: 10283947
• MDR Text Key: 199113543
• Report Number: 3008881809-2020-00210
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 19780677
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR