MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 4X20; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003110FPP0

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

It was reported that during preparation, while advancing the delivery wire of the stent, just the 1/3 of the stent was deployed.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.During visual inspection, there were no anomalies noted to the delivery catheter, but there was bending noted on the proximal end of the stent stabilizer.During functional testing, the stabilizer was advanced in the catheter and the flow diverter was able to be deployed and re-captured without difficulty.Then the flow diverter was fully deployed without difficulty and no anomalies noted to the deployed flow diverter.Information available stated that the device was stated to be in good condition, was prepared according to the dfu specifications and there was some bending noted to the proximal end of the stabilizer indicating that there was some friction experienced during the clinical procedure, even though this was not confirmed during the device analysis.It is likely that procedural factors/anatomical factors contributed to the reported and observed damages limiting the performance of the flow diverter during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.

Event Description

It was reported that during preparation, while advancing the delivery wire of the stent, just the 1/3 of the stent was deployed.There were no reported clinical consequences to the patient.

• Brand Name: SURPASS 4X20
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8380316
• MDR Text Key: 139191796
• Report Number: 3008881809-2019-00061
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M003110FPP0
• Device Lot Number: 19367732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 66