MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS45240C

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

Patient Problems Stroke/CVA (1770); Encephalopathy (1833)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported in a clinical study, that 1571 days post implant of the subject stent, the patient experienced a subacute infarct vs transient alteration of awareness.This event was reported as unrelated to the procedure, possible relation to the subject stent device, unknown relation to other devices, unknown relation to a pre-existing condition and unknown relation to medications.Patient was given unknown medication as treatment and outcome is unknown.The patient also experienced acute encephalopathy with relation to the subject stent and unknown relation to other devices.The acute encephalopathy was related to a pre-existing condition, most likely multifactorial from polypharmacy, oxycodone and volume depletion.Patient required hospitalization or prolongation of existing hospitalization and was given unknown medication as treatment.The acute encephalopathy resolved with residual effects.No further information is available.

Manufacturer Narrative

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.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 device 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.H3 other text : device remains implanted in patient.

Event Description

It was reported in a clinical study, that 1571 days post implant of the subject stent, the patient experienced a subacute infarct vs transient alteration of awareness.This event was reported as unrelated to the procedure, possible relation to the subject stent device, unknown relation to other devices, unknown relation to a pre-existing condition and unknown relation to medications.Patient was given unknown medication as treatment and outcome is unknown.The patient also experienced acute encephalopathy with relation to the subject stent and unknown relation to other devices.The acute encephalopathy was related to a pre-existing condition, most likely multifactorial from polypharmacy, oxycodone and volume depletion.Patient required hospitalization or prolongation of existing hospitalization and was given unknown medication as treatment.The acute encephalopathy resolved with residual effects.No further information is available.

• Brand Name: NEUROFORM ATLAS 4.5MM 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: 12168277
• MDR Text Key: 261749172
• Report Number: 3008881809-2021-00300
• 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
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: M003SZAS45240C
• Device Lot Number: 18493403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 57 YR