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

Model Number	M003UZAS30240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure of aneurysm embolization, there was no continues flush maintained, and the stent experienced friction when moving the system over the guidewire.It was also reported that resistance encountered between the stent delivery system, and the guide catheter as the microcatheter was not hooked up to flush, so stent did not advance smoothly to the lesion, and the stent was accidentally deployed in the microcatheter.The physician replaced it with a new device, and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure of aneurysm embolization, there was no continues flush maintained and the stent experienced friction when moving the system over the guidewire.It was also reported that resistance encountered between the stent delivery system and the guide catheter as the microcatheter was not hooked up to flush, so stent did not advance smoothly to the lesion and the stent was accidentally deployed in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual as well as functional testing cannot be performed.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.Additional information provided by the customer indicated that flush was not maintained throughout the procedure and this may have contributed to the difficulty advancing.Therefore, the as reported stent difficult/unable to advance/pullback through catheter will be assigned user error.The as reported stent deployed prematurely during use, sdw friction will be assigned undeterminable as the device was not returned and 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, a cause of undeterminable was assigned.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM 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
• MDR Report Key: 10915333
• Report Number: 3008881809-2020-00369
• Device Sequence Number: 16830387
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/01/2021

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: 07/10/2024
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 21601237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/28/2020
• Supplement Report FDA Received Date: 02/01/2021
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); SYNCHRO 10 GUIDEWIRE (STRYKER); ECHELON 10 MICROCATHETER (MEDTRONIC); SYNCHRO 10 GUIDEWIRE (STRYKER)