MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP ZERO; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003UZAS30210

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.As per the additional information, the device was confirmed in good condition prior to use and the device was prepared as per the dfu (direction for use).The patient¿s anatomy was moderately tortuous.The event description states that there was difficulties advancing the microcatheter and guide catheter to the aneurysm and multiple attempts were required before the stent was able to be deployed.It is probable that the device may have been damaged during advancement or deployment due to the anatomical factors present during the clinical procedure.A cause of procedural factors will be assigned to the reported event, as the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The device remains in patient.

Event Description

It was reported that during the procedure, the microcatheter was difficult to reach the treatment location due to unfavorable geometric angles.Then the stent (subject device) advanced through and was deployed with the microcatheter.However, the stent distal tines appeared clustered and did not fully open.The distal tines appear to be constrained with the origin of a subtle small perforator resulting in significant flow limitation within the perforator.Thus, a single weight-based bolus of integrillin was given to the patient.Follow-up catheter angiography over time shows slightly delayed by present opacification of these perforating branches.Unsuccessfully attempts were then made to catheterize the distal aspect of the stent in order to try to open the stent tines.Final angiogram shows stent tines remain constrained to the origin of the a2.The patient was assessed the morning following and overall, is doing well and is being discharged to home.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP ZERO
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8809737
• MDR Text Key: 151704459
• Report Number: 3008881809-2019-00212
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 21458713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 98