MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD45020

Device Problems Activation Failure (3270); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

It was reported that during the procedure, the subject stent did not open; therefore, the physician removed the stent out of the patient¿s anatomy.The procedure was completed successfully with another stryker device.No patient consequences reported due to this event.

Manufacturer Narrative

Product long description: unknown (surpass streamline).The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The reported event is covered in the direction 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 returned and the stent delivery wire (sdw) was kinked.The flow diverter was found to be prematurely deployed within the returned xt-27 microcatheter, deformation was also noted to the flow diverter.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors was assigned to the reported issue stent failed/ unable to open and to the analyzed issues sdw kinked/ bent, stent deployed prematurely during use and stent deformed, as the issue is associated with a product that meets stryker 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 neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).(b)(4).

Event Description

It was reported that during the procedure, the subject stent did not open; therefore, the physician removed the stent out of the patient¿s anatomy.The procedure was completed successfully with another stryker device.No patient consequences reported due to this event.

• Brand Name: UNKNOWN (SURPASS STREAMLINE)
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9226591
• MDR Text Key: 164630733
• Report Number: 3008881809-2019-00320
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2020
• Device Catalogue Number: FD45020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XT-27 MICROCATHETER (STRYKER)