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

Catalog Number M003EZAS30210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Vasoconstriction (2126); Obstruction/Occlusion (2422)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Prior procedure, the patient presented with numbness of one limb.The subject stent along with other devices (gateway balloon catheter and neuroform atlas stents) were used to treat the middle cerebral artery (mca) m1 segment with 70% stenosis.Firstly, the gateway balloon was used to dilate, and then deployed the subject stent device.After the deployment, the vessel was occluded and the proximal of the vessel had spasm which required medical intervention (as 2 other neuroform atlas stents were implanted) which caused the surgical delay of 120 minutes.However, the mca was still occluded.Post procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom possibly related to the subject stent.Hemiplegia last for three days, but muscle strength still decreased.The patient current condition is getting better.In physician¿s opinion, the subject stent device performed as intended and there was no allegation against any of the subject stent device.

Manufacturer Narrative

This is 1 of 4 reports (1st mdr).The device is not available to the manufacturer.

Manufacturer Narrative

This is 1 of 4 reports (1st mdr).H4 manufacturing date ¿ added.D4 expiration date - added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 device was not returned as it was implanted.It cannot be confirmed if the device met specification, as the device was not returned.It was reported that the operator deployed the first subject stent (3mm*21mm),and after the deployment, the vessel was occluded and the proximal of the vessel had spasm.The operator continued to deploy 4.5mm*21mm and 4.5mm*30mm stents, but the mca was still occluded.After the procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom.The risk of the reported vasospasm, patient stroke and vessel occlusion are documented in the dfu, as potential adverse events which can occur during these types of procedures.However, based on a clinical review, the cause for the vasospasm is unclear.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke¿ and ¿patient vessel occlusion¿.An assignable cause of undeterminable will be assigned to the reported ¿patient vasospasm serious.¿.

Event Description

Prior procedure, the patient presented with numbness of one limb.The subject stent along with other devices (gateway balloon catheter and neuroform atlas stents) were used to treat the middle cerebral artery (mca) m1 segment with 70% stenosis.Firstly, the gateway balloon was used to dilate, and then deployed the subject stent device.After the deployment, the vessel was occluded and the proximal of the vessel had spasm which required medical intervention (as 2 other neuroform atlas stents were implanted) which caused the surgical delay of 120 minutes.However, the mca was still occluded.Post procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom possibly related to the subject stent.Hemiplegia last for three days, but muscle strength still decreased.The patient current condition is getting better.In physician¿s opinion, the subject stent device performed as intended and there was no allegation against any of the subject stent device.

• 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: 15408014
• MDR Text Key: 299766724
• Report Number: 3008881809-2022-00444
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 23455896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: GATEWAY BALLOON (STRYKER); TWO ATLAS STENTS (STRYKER)
• Patient Outcome(s): Other; Required Intervention