MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS30210C

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

Patient Problems Stroke/CVA (1770); Visual Impairment (2138); Loss of Vision (2139)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that 1-day post-stent-assisted coiling of an unruptured aneurysm located at the basilar apex with the stent (subject device), the patient experienced a minor ipsilateral ischemic stroke with worsening of blurry vision and new vision loss.Medication was administered.According to the clinical events committee (cec), the adverse event of stroke was related to the stent and to the procedure.The adverse event was resolved without residual effects approximately 7 month-post procedure.

Manufacturer Narrative

D4: expiration date: updated.G5: pma/510k: correction.H4: manufacturing date: updated.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 stroke 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.

Event Description

It was reported that (b)(4) -day post-stent-assisted coiling of an unruptured aneurysm located at the basilar apex with the stent (subject device), the patient experienced a minor ipsilateral ischemic stroke with worsening of blurry vision and new vision loss.Medication was administered.According to the clinical events committee (cec), the adverse event of stroke was related to the stent and to the procedure.The adverse event was resolved without residual effects approximately (b)(4) month-post procedure.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM 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: 10019479
• MDR Text Key: 189723534
• Report Number: 3008881809-2020-00129
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: M003SZAS30210C
• Device Lot Number: 19218065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR