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

Model Number M003UZAS45210

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that during the procedure, a stent (subject device) was successfully deployed and visualized at the target location.The physician had difficulty removing the delivery wire of the subject stent.During this removal attempt, the subject stent pulled back from its implanted position and started pointing into the aneurysm.The physician deployed another stent into a different location and completed the procedure 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 stent was not returned and only the stent delivery wire was returned.During visual inspection, the stent delivery wire was found to be kinked and bent.Functional inspection was unable to be carried out as stent 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.The reported complaint was confirmed based on analysis and event description.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The as reported as well as the as analyzed events listed will be assigned procedural factors as this complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

It was reported that during the procedure, a stent (subject device) was successfully deployed and visualized at the target location.The physician had difficulty removing the delivery wire of the subject stent.During this removal attempt, the subject stent pulled back from its implanted position and started pointing into the aneurysm.The physician deployed another stent into a different location and completed the procedure successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM 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: 10312803
• MDR Text Key: 200019023
• Report Number: 3008881809-2020-00217
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382150
• UDI-Public: 07613327382150
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS45210
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: 21583546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Required Intervention