MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS40015

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

This is the 1 of 2 reports.Device is not available to manufacturer.

Event Description

It was reported that the stent (subject device) deployed prematurely when the physician attempted to reposition it during the procedure.The deployed subject device was recaptured using a microcatheter and was removed successfully.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Event Description

It was reported that the stent (subject device) deployed prematurely when the physician attempted to reposition it during the procedure.The deployed subject device was recaptured using a microcatheter and was removed successfully.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available.Therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint was not confirmed and it cannot be confirmed if the device met specification as the device was not returned as it was implanted in the patient.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.Additional information provided by the customer indicated that there was no damage noted to the packaging, the device was confirmed to be in good condition after unpacking, no anomalies were noted to the device prior to use, the device prepared as per the dfu, the stent delivery system was flushed with saline prior to use and the stent did not experience friction when moving the system over the guidewire.The microcatheter tip was not shaped and there was no damage noted to the microcatheter.During advancement or repositioning of the device, the inner body was not advanced independently of the outer body, continuous flush was maintained and there was no resistance encountered between the stent delivery system and the guide catheter as it was advanced to the lesion.The delivery catheter rhv was opened sufficiently to allow stent deployment.The patient¿s anatomy was severely tortuous on radial approach.The stent was advanced to the aneurysmal area, but when the physician attempted to reposition the stent, in both attempts, the stent came off the delivery system when advancing and retracting.There was no difficulty pulling back the outer body.On the first deployment, the physician made several attempts to resheath the device.He was unable to use the stent delivery system to resheath the device and finally had to capture the initially deployed stent using the microcatheter.While the device was not returned, an assignable cause of procedural factors will be assigned to the reported event as the issue is associated with a product that meets design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - PMAS
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10980976
• MDR Text Key: 220674867
• Report Number: 3008881809-2020-00389
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22294995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT-27 MICROCATHETER (STRYKER).; SURPASS EVOLVE (STRYKER).; EXCELSIOR XT-27 MICROCATHETER (STRYKER); SURPASS EVOLVE (STRYKER)
• Patient Age: 44 YR