MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003UZAS45210
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a middle cerebral artery (mca) aneurysm case, subject stent was used.Subject stent failed to open proximally in the patient¿s vessel therefore another stent was telescoped inside the first subject stent as a medical intervention.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.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 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.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was described as tortuous.It was reported that 'an atlas sent failing to open proximally.Case was completed successfully'.It was further reported that 'another stent was ¿telescoped inside¿ first stent' resulting in a medical intervention.In the follow-up gfe process, the operator answered 'not sure' to the question: was the stent delivery microcatheter retracted in a continuous movement while maintaining the position of the stent delivery wire? 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, an assignable cause of undeterminable was assigned to the as reported event of the stent failed/unable to open.
Event or Problem Description
It was reported that during a middle cerebral artery (mca) aneurysm case, subject stent was used.Subject stent failed to open proximally in the patient¿s vessel therefore another stent was telescoped inside the first subject stent as a medical intervention.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA
• Common Device Name: 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: 18473378
• Report Number: 3008881809-2024-00011
• Device Sequence Number: 6594463
• Product Code: NJE
• UDI-Device Identifier: 07613327382150
• UDI-Public: 07613327382150
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: 24037231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown