MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS30210
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and it was discovered that the stent subject device was prematurely deployed inside the catheter during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was found to be stuck inside of the microcatheter shaft approx.1cm from the hub.The stent was found to be deformed.The stent introducer sheath distal and sdw (stent delivery wire) were not returned.The microcatheter was intact.A functional inspection for the reported event, 'stent deployed prematurely during transfer' and 'stent difficult/unable to transfer' could not be performed as the stent was deployed inside the proximal shaft of the microcatheter.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 code 'stent deployed prematurely during transfer' was confirmed during analysis of the returned device.The second as reported code 'stent difficult/unable to transfer' could not be replicated.However, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that 'after tracking stent from introducer sheath into the microcatheter, scrub nurse realized that stent had deployed prematurely in the microcatheter and is separated from delivery wire'.In the follow-up gfe (good faith effort) replies it was stated that the stent prematurely deployed in the catheter hub and that there was resistance noted at the catheter hub.The stent was returned for analysis in a deployed condition inside the shaft of the returned microcatheter.The stent was located near the proximal end of the microcatheter, underneath the strain relief.Upon removal it was noted that the stent was deformed significantly towards the distal (open cell) end and there was also some minor damage noted near the proximal (closed cell) end.The stent delivery wire (sdw) and the introducer sheath were not returned for analysis.It is not possible to say with any certainty what occurred to the device and how the damage which was noted during analysis occurred.In the absence of having the introducer sheath and the sdw to inspect (not returned), one possibility is that, if the sheath was advanced too far inside the microcatheter hub / rhv ((rotating hemostasis valve), the stent can become damaged as it attempted to transfer it from the sheath into the microcatheter lumen.This is one possible explanation to explain the analysis findings.Alternatively, it is possible that the introducer sheath was initially set up correctly but subsequently moved proximally prior to stent advancement out of the sheath.This would result in a gap between the distal end of the sheath and the microcatheter lumen.If this were to occur, it is likely that, during advancement of the stent to transfer it from the sheath into the proximal end of the microcatheter lumen, the stent would partially deploy into this gap.The user will then experience increased resistance when advancing the stent through the microcatheter lumen.The as reported codes 'stent difficult/unable to transfer' and 'stent deployed prematurely during transfer' as well as the as analyzed codes 'stent deployed prematurely during use' and '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.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• 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: 20753818
• Report Number: 3008881809-2024-00556
• Device Sequence Number: 8560973
• Product Code: QCA
• UDI-Device Identifier: 07613327382211
• UDI-Public: (01)07613327382211(17)290127(10)24749180
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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 Catalogue Number: M003UZAS30210
• Device Lot Number: 24749180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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: SL- 10 CATHETER (STRYKER).
• Patient Sex: Unknown