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 03/13/2024

Event Type  malfunction  

Event Description

It was reported that during an anterior communicating artery (aca) aneurysm case significant resistance was encountered while advancing the subject stent through the microcatheter.Additional force was applied to facilitate advancement, resistance persisted even after the stent had entered the microcatheter.The subject stent and microcatheter were retrieved and replaced with a microcatheter and stent from the same catalog to complete the procedure.Additional information was received on the (b)(6) 2024 clarifying that the stent prematurely deployed in the proximal end of the microcatheter shaft.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the stent was confirmed to have been deployed within the microcatheter.Ptfe was noted on the stent when removed from the microcatheter.The stent was deformed and the sdw was kinked.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 defect stent deployed prematurely during use was confirmed during the analysis.The reported defects stent difficult/unable to advance or pullback through catheter and stent difficulty/unable to transfer could not be duplicated; 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 states that the device was prepared for use as per the directions for use, the device confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The operator prepared to used a microcatheter to deliver the stent.Flushed and delivered the stent and big resistance was encountered during delivery of it into microcatheter.Added some force to push and the stent could be advanced slowly but after the stent went into microcatheter big resistance was still encountered.An assignable cause of procedural factors will be assigned to the reported defects stent difficult/unable to advance or pullback through catheter, stent difficult/unable to transfer and stent deployed prematurely during use and to the analysed defects stent deployed prematurely during use, sdw kinked/bent and stent deformed, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during an anterior communicating artery (aca) aneurysm case significant resistance was encountered while advancing the subject stent through the microcatheter.Additional force was applied to facilitate advancement, resistance persisted even after the stent had entered the microcatheter.The subject stent and microcatheter were retrieved and replaced with a microcatheter and stent from the same catalog to complete the procedure.Additional information was received on the 29th of march 2024 clarifying that the stent prematurely deployed in the proximal end of the microcatheter shaft.No clinical consequences were reported to the patient due to this event.

• 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: 19052796
• MDR Text Key: 340340735
• Report Number: 3008881809-2024-00150
• 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: 05/21/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 24349095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: Asian