MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45210

Device Problems Fracture (1260); Activation Failure (3270)

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

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that patient underwent embolization procedure of an unruptured intracranial aneurysm (ia) at the paraclinoid segment of the left internal carotid artery (ica) in 2015.During five years follow-up, there was major recurrence of the ia.Physician decided to perform a second coil embolization using the stent assisted catheter jailing technique.While deploying the subject stent its distal end was flared in the site and one third of the stent was partially deployed as usual.Suddenly, the stent delivery microcatheter partially withdrew to the proximal part of the parent artery and the physician considered the possibilities of a subject stent fracture or stretching.To stabilize the damaged stent and remodel the aneurysm neck, an additional stent was implanted into the distal part of the subject stent with telescoping manner.Successful coil embolization was achieved with a small neck remnant.During the procedure, the proximal end of the subject stent was gradually moved distally.The patient recovered from the intervention without any neurological deficit.Dual antiplatelet regimen was continued and 1 year, postoperative fluoroscopy and mra was also performed.The fluoroscopy showed no change in length from the proximal to the distal marker of the subject stent.The subject stent was confirmed to be stretched on the magnetic resonance time of flight (mr tof) imaging.The mr tof images showed subject stent struts with poor wall apposition in the cavernous ica.Additionally, a gap was noticed between the vessel wall and struts due to ovalization of the subject stent.The subject stent struts were observed as longitudinally elongated shapes without definite disconnection.During deployment of the subject stent using the jailing technique with the aneurysm selecting microcatheter, stent strut may have been hooked by the microcatheter already inserted in the ia.No additional information available.

Manufacturer Narrative

The device remains implanted inside the patient's vasculature.

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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The distal end of the stent was flared in the expected site, and approximately one-third of the stent was partially deployed as usual.Suddenly, the stent-delivery microcatheter partially withdrew to the proximal part of the parent artery.We considered the possibilities of a stent fracture or stretching of the stent.The stretched neuroform atlas® stent was confirmed on magnetic resonance time of flight (mr-tof) imaging.The mr-tof images showed stent struts with poor wall apposition in the cavernous ica.Additionally, we noticed a gap between the vessel wall and the stent strut due to ovalization of the stent.The stent struts were observed as longitudinally elongated shapes without definite disconnection.During deployment of the stent using the jailing technique with the aneurysm-selecting microcatheter, the stent strut may have been hooked by the microcatheter already inserted in the ia.The device was not returned for analysis, as it had been implanted.It is probable that the stent may have been stretched and fractured in during the attempt to deploy the stent with the jailing technique causing the reported events.However this cannot be definitively determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint of label contents incorrect/inadequate, stent broken/fractured during use, stent deformed, stent failed/unable to open and device interaction with another device.

Event Description

It was reported that patient underwent embolization procedure of an unruptured intracranial aneurysm (ia) at the paraclinoid segment of the left internal carotid artery (ica) in 2015.During five years follow-up, there was major recurrence of the ia.Physician decided to perform a second coil embolization using the stent assisted catheter jailing technique.While deploying the subject stent its distal end was flared in the site and one third of the stent was partially deployed as usual.Suddenly, the stent delivery microcatheter partially withdrew to the proximal part of the parent artery and the physician considered the possibilities of a subject stent fracture or stretching.To stabilize the damaged stent and remodel the aneurysm neck, an additional stent was implanted into the distal part of the subject stent with telescoping manner.Successful coil embolization was achieved with a small neck remnant.During the procedure, the proximal end of the subject stent was gradually moved distally.The patient recovered from the intervention without any neurological deficit.Dual antiplatelet regimen was continued and 1 year, postoperative fluoroscopy and mra was also performed.The fluoroscopy showed no change in length from the proximal to the distal marker of the subject stent.The subject stent was confirmed to be stretched on the magnetic resonance time of flight (mr tof) imaging.The mr tof images showed subject stent struts with poor wall apposition in the cavernous ica.Additionally, a gap was noticed between the vessel wall and struts due to ovalization of the subject stent.The subject stent struts were observed as longitudinally elongated shapes without definite disconnection.During deployment of the subject stent using the jailing technique with the aneurysm selecting microcatheter, stent strut may have been hooked by the microcatheter already inserted in the ia.No additional information available.

• Brand Name: NEUROFORM ATLAS 4.5MM 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: 17095940
• MDR Text Key: 316855703
• Report Number: 3008881809-2023-00292
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 21954238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female