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

Catalog Number M003UZAS40210

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that during aneurysm stent coil procedure the operator was advancing the subject stent through the microcatheter.Friction was noted when advancing the subject stent to the target lesion and fluoroscopy showed that no subject stent was present on the delivery wire.It was concluded that the subject stent deployed prematurely inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.D4 expiration date added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the stent delivery wire (sdw) was noted to be kinked/bent in several locations.The stent introducer sheath distal tip was noted to be damaged.A 0.0158" mandrel was advanced through the microcatheter with no resistance noted.The stent was not returned with the device.Functional inspection to test the reported event: ¿stent deployed prematurely during use¿ was not required as the event was visually confirmed.Functional inspection to test the reported event: ¿stent difficult/unable to advance or pullback through catheter¿ was not performed as the stent was not returned for analysis.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 event 'stent deployed prematurely during use' was visually (indirectly) confirmed during inspection (it was not present still loaded on the sdw and was not present in the introducer sheath).The reported event 'stent difficult/unable to advance or pullback through catheter' could not be duplicated as the stent was not returned for analysis.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.Additional information provided by the customer indicated that the device was prepared as per the dfu.The device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.It was reported that the 'issue occurred during procedure during advancement through microcatheter- after introducing and before tiger stripes entered the stent introducer sheath but did not cause any patient issues/ no adverse consequences nor case delays.The stent deployed prematurely.It was swapped out for a new stent in the same size with no issues, as well as new microcatheter straight since the one used with this stent now had a stent inside of it and couldn't be used in the case'.The stent was not returned for analysis.The microcatheter lumen was inspected using a 0.0158" mandrel and the stent was not present inside it.The introducer sheath was returned and the distal tip had some minor damage present.The stent delivery wire (sdw) was also returned separately (not loaded inside the introducer sheath) and was kinked/bent at multiple points along its length.Given the minor damage noted to the distal tip opening of the introducer sheath and the deformation noted to the sdw, as well as the event description which notes friction while advancing (the stent) inside the microcatheter, it is possible that the introducer sheath was initially advanced slightly too far distally (which would cause minor deformation of the tip) 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 while attempting to advance the stent through the microcatheter.This is one possible explanation to explain the analysis findings.An assignable cause of procedural factors has been assigned to the reported events: 'stent deployed prematurely during use' and 'stent difficult/unable to advance or pullback through catheter' and analysed events: ¿stent deployed prematurely during use¿, ¿sdw kinked/bent¿ and ¿stent introducer sheath distal tip damaged¿ as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was reported to have been used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

It was reported that during aneurysm stent coil procedure the operator was advancing the subject stent through the microcatheter.Friction was noted when advancing the subject stent to the target lesion and fluoroscopy showed that no subject stent was present on the delivery wire.It was concluded that the subject stent deployed prematurely inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM 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
• 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: 18881908
• MDR Text Key: 337665581
• Report Number: 3008881809-2024-00101
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382174
• UDI-Public: 07613327382174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: M003UZAS40210
• Device Lot Number: 22111907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER (STRYKER).