MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30240

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

Patient Problems Occlusion (1984); Stenosis (2263); Thromboembolism (2654)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that core lab imaging (angiography) 12-16 month-post stent-assisted coil embolization procedure with the subject stent for an aneurysm located at the right middle cerebral artery (mca), core lab imaging revealed 100% parent artery occlusion and thromboembolism in the aneurysm neck and distal branch.The facility did not report any adverse consequences to the patient at the follow-up visits during the same times.

Event Description

It was reported that core lab imaging (angiography) 12-16 month-post stent-assisted coil embolization procedure with the subject stent for an aneurysm located at the right middle cerebral artery (mca), core lab imaging revealed 100% parent artery occlusion and thromboembolism in the aneurysm neck and distal branch.The facility did not report any adverse consequences to the patient at the follow-up visits during the same times.Additional information received on 28-jan-2020 that per clinical events committee (cec) adjudication, in-stent stenosis was confirmed and as related to the subject device.Stent thrombosis was not confirmed.

Manufacturer Narrative

B5: executive summary: corrected with additional information: per clinical events committee (cec) adjudication, in-stent stenosis was confirmed and as related to the subject device.Stent thrombosis was not confirmed.D4: expiration date: updated.G4: reportability awareness date: reportability awareness date: updated based on additional information received.H4: manufacturing date: updated.H6: patient code: corrected.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported in-stent stenosis is a known and anticipated complication to these types of procedures and patient condition and are listed as such in the device dfu.Based on the information available an assignable cause of ¿anticipated procedural complication¿ has been assigned to this event.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9618585
• MDR Text Key: 176100697
• Report Number: 3008881809-2020-00015
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: M003EZAS30240
• Device Lot Number: 19192953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR