MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 5 X 50 SURPASSTM SYSTEM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number 123FPP

Device Problem Activation Failure (3270)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the flow diverter stent was not fully opened in the mid-section and was returned on the delivery system.There was some slight deformation noted to the distal end of the flow diverter.There were procedural fluids noted on the stent.During functional testing, the delivery catheter was flushed and a lot of blood exited.Stabilizer/ stent were advanced ¿ there was a lot of resistance experienced due to the blood within the catheter.When the stabilizer exited there was further dried blood/ thrombus.Once the blood was removed from the stabilizer it was removed from the catheter without difficulty.The stent was soaked for a few minutes and the procedural fluids dissolved and the stent opened.The returned device confirmed the as reported event.The delivery system was blocked/ occluded with blood, which indicated a lack of continuous flush, however this cannot be definitively determined.Procedural fluids & blood were noted on the returned flow diverter which when soaked and procedural fluids removed the flow diverter opened fully.It is probable that the presence of blood and procedural fluids within the delivery system and on the flow diverter caused the flow diverter to partially open causing the stabilizer to become stuck in the flow diverter.Therefore, an assignable cause of procedural factors has been assigned to as reported stent failure to open, stent delivery wire stuck in the stent, and the analyzed stent failure to open, stent deformed, catheter shaft blocked/ occluded and stent stabilizer/ catheter friction.It cannot be determined that the reported patient complications (hemi-paresis) is related to the device.However, neurological deficit, in this case hemiparesis is a known risk associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.

Event Description

It was reported that during procedure a first flow diverter stent (first subject device) did not open and seemed "stuck" to the pusher.The stent was removed from the patient¿s body and replaced by a second flow diverter stent.The second stent did not open distally and partially deployed.It was removed from the patient¿s body and replaced by a third non-stryker flow diverter that was implanted successfully.The patient was woken and started to present with a hemiparesis that was resolved approximately 1 week later.According to the physician, the relationship of the hemiparesis to any device is unknown.

• Brand Name: 5 X 50 SURPASSTM SYSTEM
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 8269911
• MDR Text Key: 133864642
• Report Number: 3008881809-2018-00494
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Catalogue Number: 123FPP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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): Other
• Patient Age: 73 YR