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

Catalog Number M003EZAS45210

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

Patient Problems Stroke/CVA (1770); Paralysis (1997)

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

This is 2 of 4 reports (2nd mdr).The device is not available to the manufacturer.

Event Description

Prior procedure, the patient presented with numbness of one limb.The first stent (3mm*21mm) was used along with other devices (gateway balloon catheter and neuroform atlas stents) to treat the middle cerebral artery (mca) m1 segment with 70% stenosis.Firstly, the gateway balloon was used to dilate, and then deployed the first stent device.After the deployment, the vessel was occluded and the proximal of the vessel had spasm which required medical intervention as the subject stent neuroform atlas stent (4.5mm x 21mm) was 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.

Event Description

Prior procedure, the patient presented with numbness of one limb.The first stent (3mm/21mm) was used along with other devices (gateway balloon catheter and neuroform atlas stents) to treat the middle cerebral artery (mca) m1 segment with 70% stenosis.Firstly, the gateway balloon was used to dilate, and then deployed the first stent device.After the deployment, the vessel was occluded and the proximal of the vessel had spasm which required medical intervention as the subject stent neuroform atlas stent (4.5mm x 21mm) was 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 2 of 4 reports (2nd mdr).H4: manufacturing date: added.H3: device evaluated by mfg ¿updated.H3: summary attached - updated.D4: expiration date - added.D9: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.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.During visual inspection, the sdw (stent delivery wire) was seen to be kinked, the introducer sheath was intact, and the stent was not returned as it was implanted.A functional test was not required.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 event was unable to be confirmed during analysis as the event is procedure/patient related.The stent was not returned as it was implanted.It cannot be confirmed if the stent met specification, as the stent was not returned.It was reported that the operator deployed the first stent (3mm/21mm), the vessel was occluded and the proximal of the vessel had spasm.The operator continued to deploy the subject (4.5mm/21mm )stent and (4.5mm/30mm) stent, 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 patient stroke is documented in the dfu, as potential adverse events which can occur during these types of procedures, therefore an assignable cause of anticipated procedural complication, will be assigned to the reported ¿patient stroke.¿ the sdw and introducer sheath were returned and the sdw was noted to be kinked, this is not likely to be related to the reported event.It is probable that the sdw was kinked during use, therefore an assignable cause of procedural factors will be assigned to the analyzed ¿sdw kinked/bent.¿.

• 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: 15408132
• MDR Text Key: 299724620
• Report Number: 3008881809-2022-00445
• 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: M003EZAS45210
• Device Lot Number: 23440708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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): Required Intervention; Other