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

Catalog Number	M003UZAS40210
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2023
Type of Reportable Event	Malfunction
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.During visual/microscopic inspection, the device was returned with microcatheter.The device was found to be advanced into microcatheter.The stent was found to be partially deployed from the catheter.The stent was found to be deformed.The distal part of the stent delivery wire sdw was found to be slightly kinked/bent.The stent introducer sheath was not returned.During functional inspection, stent difficult/unable to advance or pullback through catheter functional test failed.It was difficult to flush the device due to significant friction.The stent was advanced on the table; however significant friction was noted.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 event was confirmed during the analysis.The device did not meet specifications when received for complaint investigation based on analysis results.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'tortuosity was above average'.The device was analyzed.The returned stent was found to be partially deployed form the microcatheter.The stent was found to be deformed and the sdw was found to be kinked/bent.This damages were causing friction during functional test.It is probable that the moderately tortuous anatomy may have caused friction, damages to the device and the reported issue.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'stent difficult/unable to advance or pullback through catheter and to as analyzed stent partial deployment, stent deformed, sdw kinked/bent as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
Analysis of the returned device found that the subject stent was partially deployed.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: NEUROFORM ATLAS 4.0MM 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: 18267082
• Report Number: 3008881809-2023-00571
• Device Sequence Number: 7672549
• Product Code: NJE
• UDI-Device Identifier: 07613327382174
• UDI-Public: 07613327382174
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• Device Catalogue Number: M003UZAS40210
• Device Lot Number: 22111905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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: SL10 MICROCATHETER (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Male