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

Catalog Number M003EZAS30210

Device Problem Premature Activation (1484)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that during stent assisted aneurysm embolization procedure, physician used a microcatheter to deliver the subject stent.The physician felt resistance while advancing the subject stent within the microcatheter and the subject stent deployed prematurely within the microcatheter.The subject stent was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during stent assisted aneurysm embolization procedure, physician used a microcatheter to deliver the subject stent.The physician felt resistance while advancing the subject stent within the microcatheter and the subject stent deployed prematurely within the microcatheter.The subject stent was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the device was returned.The sdw (stent delivery wire) was noted to be kinked/bent in several locations.The stent introducer sheath was noted to be intact.The microcatheter was inspected and noted to be undamaged.The stent was noted to be stuck in the proximal strain relief of the microcatheter.During functional inspection, stent deployed prematurely during use was not applicable.Stent difficult/unable to advance or pullback through catheter - 0.0158" mandrel was advanced into the microcatheter distal end and resistance was felt at the proximal strain relief of the microcatheter.The 0.0158" mandrel was then advanced into the proximal end of the microcatheter and resistance felt in the same area.The microcatheter was cut at the proximal strain relief to find the stent causing the resistance.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 ¿stent deployed prematurely during use¿ was visually (indirectly) confirmed during inspection (it was deployed inside the lumen of the microcatheter and the stent delivery wire [sdw] was returned separately).The reported ¿stent difficult/unable to advance or pullback through catheter¿ was confirmed during analysis.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 for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging and 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 and the patient¿s anatomy was described as 'not tortuous'.It was reported that 'the operator used microcatheter to deliver a stent, but the stent could not be advanced in microcatheter, and deployed at 60cm from proximal of the microcatheter.Withdrew the whole system and used another microcatheter and stent to continue the procedure.No impact to the patient.The stent was returned for analysis still loaded inside the lumen of the returned microcatheter.Several attempts were made to remove the stent from both the proximal end and distal end of the microcatheter without success.The microcatheter was next cut at the strain relief and the stent was confirmed to be present but it could not be released.The stent delivery wire (sdw) was also returned separately (not loaded inside the introducer sheath) and was kinked/bent near the distal end of the wire and at other locations along the wire length.The introducer sheath was returned and inspected and noted to be undamaged.Given the lack of 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 increasing resistance when the stent was being advanced inside the microcatheter, 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 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 as reported ¿stent difficult/unable to advance or pullback through catheter¿ and ¿stent deployed prematurely during use¿ and as analyzed ¿stent difficult/unable to advance or pullback through catheter¿, ¿stent deployed prematurely during use¿ and ¿sdw kinked/bent¿ 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.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
• 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: 18736146
• MDR Text Key: 336862253
• Report Number: 3008881809-2024-00070
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/02/2024

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: M003EZAS30210
• Device Lot Number: 24398517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: EXCELSIOR SL10 MICROCATHETER (STRYKER).
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: Asian