MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS40240C

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

Patient Problem Nausea (1970)

Event Date 01/14/2017

Event Type  Injury  

Manufacturer Narrative

This is the first of 2 reports.Subject device remains implanted.

Event Description

It was reported that approximately 2 weeks post-procedure of stent -assisted coiling for an aneurysm located at the basilar apex with the stent (subject device), the patient experienced nausea.Patient was treated with medication and the nausea was resolved without any residual effects the next day.According the clinical events committee (cec) adjudication, the nausea was related to the subject device.

Event Description

It was reported that approximately 2 weeks post-procedure of stent -assisted coiling for an aneurysm located at the basilar apex with the stent (subject device), the patient experienced nausea.Patient was treated with medication and the nausea was resolved without any residual effects the next day.According the clinical events committee (cec) adjudication, the nausea was related to the subject device.

Manufacturer Narrative

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 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 patient nausea is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM 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 ; IE NA
• MDR Report Key: 10033433
• MDR Text Key: 190165507
• Report Number: 3008881809-2020-00139
• 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: study
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: M003SZAS40240C
• Device Lot Number: 18636375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ATLAS STENT (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR