MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD50020

Device Problem Fracture (1260)

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

Event Date 05/28/2020

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.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.The product was not returned for the analysis and the reported defects could not be confirmed.No anomalies were noted to the device prior to the procedure and the dfu was followed during the preparation of the device.As per the event description, 'the physician reported the fact that: physician had manipulated and resheathed the stent more than 3 times, especially with 2 pipelines in place.During mid deployment the resheathing pad fell off the device, however physician had the cat 5 distal enough to deploy the stent safely.Managed to deploy the stent safely.However, the resheathing pad fell off from the device while deploying'.While the dfu states "caution: do not attempt to partially deploy and recapture the implant more than three times or a loss of resheath performance may occur" it is most probable that the anatomical factors present during the clinical procedure contributed to the fact the device was resheath more than 3 times and therefore to the subsequent fracture and resheathing issue.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 according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during the procedure, the physician made several attempts to manipulate and resheath the stent (subject device) for deployment.The part of the stabilizer of the subject stent broke during mid deployment attempt.The subject stent was deployed safely using a microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 5.0MM X 20MM - 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: 10667877
• MDR Text Key: 214173051
• Report Number: 3008881809-2020-00302
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Catalogue Number: FD50020
• Device Lot Number: 22047736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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