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

Catalog Number M003EZAS30240

Device Problem Fracture (1260)

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

Event Date 02/25/2024

Event Type  malfunction  

Event Description

It was reported that during anterior communicating artery (acom artery) aneurysm embolization case, resistance was felt while inserting and advancing subject stent through the microcatheter.When subject stent was observed under digital subtraction angiography (dsa), the marker of the subject stent were not visible under fluoroscopy.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

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 and microscopic inspection, it was observed that the stent delivery wire (sdw) was kinked/bent and was the only part of the subject device system that was returned for analysis.The subject stent and introducer sheath was not returned for analysis.Functional testing could not be performed as subject 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 as reported code 'ro marker(s) detached/separated/not visible under fluoroscopy' was assigned undeterminable as the subject stent was not returned for analysis.The remaining as reported codes 'stent difficult/unable to advance or pullback through catheter' and 'stent difficult/unable to transfer' could not be duplicated as the sdw was the only part of the subject device system which was returned.However, the analysis results are consistent with the reported event.The sdw did not meet specifications when received for complaint investigation based on visual inspection.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.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 'moderately tortuous'.It was reported that 'the operator prepared to use subject stent to treat.Prepared and flushed the stent and used microcatheter to deliver it.However, resistance was encountered during delivery and under digital subtraction angiography (dsa) the marker of the subject stent was not seen very clearly.The subject stent could not be advanced out of microcatheter so the operator replaced it with another stent to go through the same microcatheter to finish the procedure'.In the follow-up good faith efforts (gfe) process it was clarified by the user that the ro marker was checked and was present on the stent following its removal from the microcatheter.The subject stent was not returned although it was stated to have been removed from the microcatheter.The introducer sheath was also not returned for analysis.The sdw was the only part of the subject device system that was returned for analysis.The sdw was kinked/bent towards the distal end of the wire.There are reasons why the stent might experience resistance when being advanced through the microcatheter and many of these relate to the initial transfer of the stent from the introducer sheath, through the rhv and into the microcatheter.In the absence of any other parts of the subject device system to inspect, is it not possible to determine what might have triggered the complaint on this particular occasion.The as reported code 'ro marker(s) detached/separated/not visible under fluoroscopy' will be assigned undeterminable as the subject stent was not available for analysis.The remaining two as reported codes 'stent difficult/unable to advance or pullback through catheter' and 'stent difficult/unable to transfer' and as well as the as analysed code ¿sdw kinked/bent¿ 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 and/or anatomical factors during use.

Event Description

It was reported that during anterior communicating artery (acom artery) aneurysm embolization case, resistance was felt while inserting and advancing subject stent through the microcatheter.When subject stent was observed under digital subtraction angiography (dsa), the marker of the subject stent were not visible under fluoroscopy.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM 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: 18926875
• MDR Text Key: 337954804
• Report Number: 3008881809-2024-00113
• 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
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30240
• Device Lot Number: 24349098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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 SL-10 MICROCATHETER (STRYKER).
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: Asian