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

Model Number	M003SZAS40210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received and the reported lot number was not confirmed as the packaging was not returned with the device.On visual/microscopic inspection, the stent delivery wire (sdw) was seen to be broken/fractured and kinked bent.The stent was stuck within the catheter hub.The stent was removed from the catheter and was seen to be deformed.Functional inspection was not carried out due to damage.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.The as reported can be confirmed based on analysis.The as reported stent difficult/unable to transfer as well as the as analyzed sdw broken/fractured during use, sdw kinked bent, stent deformed will be assigned procedural factors 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
The subject stent was returned for analysis and it was discovered that the stent delivery wire was broken/fractured during use.There was no clinical consequence to the patient reported as a result of this event.

• Brand Name: NEUROFORM ATLAS 4.0MM X 21MM NO TIP- HDE
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12250833
• Report Number: 3008881809-2021-00319
• Device Sequence Number: 20006013
• Product Code: NJE
• UDI-Device Identifier: 07613252656197
• UDI-Public: 07613252656197
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/30/2021

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: 09/28/2025
• Device Model Number: M003SZAS40210
• Device Catalogue Number: M003SZAS40210
• Device Lot Number: 22481273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICRO CATHETER (STRYKER)