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 Aneurysm (1708); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that the patient had an aneurysm recanalization approximately 2 years after the first procedure.The physician planned to coil the aneurysm through an already existing stent.During the second retreatment procedure, the physician noticed the right posterior communicating artery was not perfusing well anymore.It was decided to add the subject stent to improve perfusion and medication was given to resolve possible blood clots.Physician then noticed the subject stent had a stenosis.In the physicians opinion, it did not look like a stent stenosis due to thrombosis.It appeared more like the coil mass inside the aneurysm compressed the stent back into the vessel and squeezed it.Patient had good working collateral vessels and there were no clinical consequences to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added, d4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.It was reported that during intervention he noticed a stenosis of the stent.According to the physician, it did not look like in stent stenosis due to thrombosis.It looked more like the coil compressed the stent back into the vessel and squeezed it in both cases.The device was not returned as it had been implanted.The risk of the reported events are anticipated in nature as per the device risk documentation, however in this case it is possible that the event may be related to the coil mass encroaching into the parent vessel.An probable assignable cause of procedural factors will be assigned to the reported complaint, 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.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient had an aneurysm recanalization approximately 2 years after the first procedure.The physician planned to coil the aneurysm through an already existing stent.During the second retreatment procedure, the physician noticed the right posterior communicating artery was not perfusing well anymore.It was decided to add the subject stent to improve perfusion and medication was given to resolve possible blood clots.Physician then noticed the subject stent had a stenosis.In the physicians opinion, it did not look like a stent stenosis due to thrombosis.It appeared more like the coil mass inside the aneurysm compressed the stent back into the vessel and squeezed it.Patient had good working collateral vessels and there were no clinical consequences 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: 12783440
• MDR Text Key: 284841020
• Report Number: 3008881809-2021-00473
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: 23053003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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: TARGET COILS (STRYKER)
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female