MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Model Number NOT APPLICABLE

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

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Stenosis (2263); Confusion/ Disorientation (2553)

Event Date 05/04/2019

Event Type  Injury  

Manufacturer Narrative

The subject device remains implanted in patient.

Event Description

It was reported the patient underwent stent (subject device) assisted coil embolization procedure of an unruptured left middle cerebral artery(mca) aneurysm.The procedure was completed, and the imaging did not reveal any problem after the procedure.However, three months post-procedure, the angiogram confirmed stent occlusion of the m2 segment of the anterior division of the left mca and stroke.There was thrombosis and in-stent stenosis noted.The patient suffered from confusion which cleared up prior to discharge.Physician reported patient was discharged in stable condition with mild gait difficulty and recommended outpatient physical therapy and continuation of dual antiplatelet therapy (dapt) medication plavix and aspirin.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.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 issue is a known and anticipated complications and is covered in the device directions for use, therefore, a cause of anticipated procedural complication will be assigned to the investigation.

Event Description

It was reported the patient underwent stent(subject device) assisted coil embolization procedure of an unruptured left middle cerebral artery(mca) aneurysm.The procedure was completed, and the imaging did not reveal any problem after the procedure.However, three months post-procedure, the angiogram confirmed stent occlusion of the m2 segment of the anterior division of the left mca and stroke.There was thrombosis and in-stent stenosis noted.The patient suffered from confusion which cleared up prior to discharge.Physician reported patient was discharged in stable condition with mild gait difficulty and recommended outpatient physical therapy and continuation of dual antiplatelet therapy (dapt) medication plavix and aspirin.No further information is available.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8659244
• MDR Text Key: 146680492
• Report Number: 3008881809-2019-00150
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 21011006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 90