MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITH TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003ETAS30210

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 06/10/2017

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that during aneurysm stenting procedure with the subject stent, the patient experienced a transitory complication with thrombus at the neck, responsible of slowing flow in right anterior cerebral artery.There was resolution of the thrombus with a bolus of reopro in situ and hemodynamical optimization.After procedure, the patient showed an isolate event of right arm dyspraxia, spontaneously resolved with no recurrence in less that 24 hours from procedure.The physician confirmed that the neck thrombus was related to both subject stent and procedure.The physician also confirmed that the right arm dyspraxia was a consequence of the thrombus.Patient medical history includes hypertension, current smoker, previous hemorrhagic stroke ((b)(6) 2017), previous treatment of non-target aneurysm.

Event Description

It was reported that during aneurysm stenting procedure with the subject stent, the patient experienced a transitory complication with thrombus at the neck, responsible of slowing flow in right anterior cerebral artery.There was resolution of the thrombus with a bolus of reopro in situ and hemodynamical optimization.After procedure, the patient showed an isolate event of right arm dyspraxia, spontaneously resolved with no recurrence in less that 24 hours from procedure.The physician confirmed that the neck thrombus was related to both subject stent and procedure.The physician also confirmed that the right arm dyspraxia was a consequence of the thrombus.Patient medical history includes hypertension, current smoker, previous hemorrhagic stroke (4/5/2017), previous treatment of non-target aneurysm.

Manufacturer Narrative

D4: expiration date: updated h4: manufacturing date: updated the device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event could not be confirmed.The intended use for the device was for treatment.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 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.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

Manufacturer Narrative

The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable e.Vent for the device in question.H3 other text : device remains in patient.

Event Description

It was reported that during aneurysm stenting procedure with the subject stent, the patient experienced a transitory complication with thrombus at the neck, responsible of slowing flow in right anterior cerebral artery.There was resolution of the thrombus with a bolus of reopro in situ and hemodynamical optimization.After procedure, the patient showed an isolate event of right arm dyspraxia, spontaneously resolved with no recurrence in less that 24 hours from procedure.The physician confirmed that the neck thrombus was related to both subject stent and procedure.The physician also confirmed that the right arm dyspraxia was a consequence of the thrombus.Patient medical history includes hypertension, current smoker, previous hemorrhagic stroke (4/5/2017), previous treatment of non-target aneurysm.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITH TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 9684282
• MDR Text Key: 178380876
• Report Number: 3008881809-2020-00036
• 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: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: M003ETAS30210
• Device Lot Number: 19611386
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 12/11/2020
• Supplement Dates FDA Received: 03/11/2020; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention