MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS30240C

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

Patient Problems Headache (1880); Transient Ischemic Attack (2109)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 and it cannot be confirmed that the device met specification, as the device was not returned.Based on the information provided in the complaint, it was reported that the patient suffered a headache 22 months post-procedure and transient ischemic attack (tia) 42 months post-procedure with possible relation to neuroform atlas device.Device remains implanted in patient.

Event Description

It was reported during the clinical study 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation, the patient experienced headache.The patient was given medication and had a prolonged hospital stay.It was resolved without sequelae and the patients medical condition was good.There were no other clinical consequences to the patient.

Event Description

It was reported during the clinical study 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation, the patient experienced headache.The patient was given medication and had a prolonged hospital stay.It was resolved without sequelae and the patients medical condition was good.There were no other clinical consequences to the patient.Corrected executive summary: it was reported during the clinical study, the patient experienced a transient ischemic attack (tia) 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation.It was also reported that at 22 months post stenting and at 2 years post stenting, the patient experienced headaches.The patient was given medication and had a prolonged hospital stay.The events resolved without sequelae and the patient¿s medical condition was good.There were no other reported clinical consequences to the patient.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 and it cannot be confirmed that the device met specification, as the device was not returned.Based on the information provided in the complaint, it was reported that the patient suffered a headache 22 months post-procedure and transient ischemic attack (tia) 42 months post-procedure with possible relation to neuroform atlas device.Additional information received on 5 feb 2021 confirmed the patient suffered a headache 2y post-procedure with possible relation to neuroform atlas device.H3 other text: device remains implanted in patient.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 and it cannot be confirmed that the device met specification, as the device was not returned.Based on the information provided in the complaint, it was reported that the patient suffered a transient ischemic attack (tia) 42 months post-procedure with possible relation to neuroform atlas device.Additional information received on 5 feb 2021 confirmed the patient suffered a headache 2y post-procedure with possible relation to neuroform atlas device.Additional information 8-march-2021 stated that the patients headache 22 months post-procedure had been upgraded to a transient ischemic attack (tia) with possible relation to neuroform atlas device.H3 other text : device remains implanted in patient.

Event Description

It was reported during the clinical study 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation, the patient experienced headache.The patient was given medication and had a prolonged hospital stay.It was resolved without sequelae and the patients medical condition was good.There were no other clinical consequences to the patient.Corrected executive summary: it was reported during the clinical study, the patient experienced a transient ischemic attack (tia) 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation.It was also reported that at 22 months post stenting and at 2 years post stenting, the patient experienced headaches.The patient was given medication and had a prolonged hospital stay.The events resolved without sequelae and the patient¿s medical condition was good.There were no other reported clinical consequences to the patient.Corrected executive summary: it was reported during the clinical study, that the patient experienced two transient ischemic attacks (tia).One at 22 months post procedure and the second at 42 months post stent (subject device) assisted coil embolization of an aneurysm located at the right middle cerebral artery (mca) bifurcation.It was also reported that at 2 years post stenting, the patient experienced a headache.The patient was given medication and had a prolonged hospital stay.The events resolved without sequelae and the patient¿s medical condition was good.There were no other reported clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP- IDE
• 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: 11380580
• MDR Text Key: 233733663
• Report Number: 3008881809-2021-00100
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: M003SZAS30240C
• Device Lot Number: 18575235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TARGET COILS (STRYKER)
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 50 YR