MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD45017

Device Problem Premature Activation (1484)

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

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent delivery wire (sdw) was returned within a dispenser hoop but the introducer sheath was not returned.The sdw was kinked at 40cm & 159cm from the proximal end and the returned catheter was noted to be flattened at 9.5cm from the distal end.During functional test, a 0.027¿ patency mandrel was advanced through the returned microcatheter and some resistance was experienced near the flattened section.When the patency mandrel was advanced to the distal tip of the microcatheter the subject stent was seen deployed from the microcatheter.There was some slight deformation noted to the both ends of the subject stent flow diverter.The reported event was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device 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.As per the complaint information, the tight curve at the middle part of the stent did not open despite many manipulations by the physician.The proximal part of the stent also opened but even after 3 times of resheathing the stent and reopening with different manipulations, the curve did not oppose to the wall of the vessel and the stent was removed.The patient's anatomy was of medium tortuosity and the appropriate size stent was selected for the treatment site.It is probable that the device was damaged during navigation through the patient's anatomy causing the reported failure of the stent to open and oppose the vessel wall.An assignable cause of procedural factors will be assigned to the reported and analysed events, as the issue is associated with a product that meets 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.

Event Description

The stent (subject device) was returned for analysis and the device investigation revealed that the subject stent was seen to be deployed prematurely during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 4.5MM X 17MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 11356824
• MDR Text Key: 234219248
• Report Number: 3008881809-2021-00091
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P170024/S003
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Catalogue Number: FD45017
• Device Lot Number: 21707565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• 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