MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 40MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD50040

Device Problem Premature Activation (1484)

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

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that the subject stent got prematurely deployed inside the patient vessel.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added d4 expiration date - added due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject flow diverter stent was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.In the physician¿s opinion the cause of the reported issue was that it got premature deployment inside the patient.The subject flow diverter stent was not recaptured back into the microcatheter.There was no resistance between the delivery catheter and the pusher.The anatomy location of intended treatment was internal carotid artery (ica) cavernous.There was no resistance encountered during navigation of the subject flow diverter stent device to the target lesion and there was no resistance during advancement of the stent delivery system through the patient¿s anatomy.The physician was not able to deliver the subject flow diverter stent device to the target lesion.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the as reported code ¿stent deployed prematurely during use¿.

Event Description

It was reported that the subject stent got prematurely deployed inside the patient vessel.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 5.0MM X 40MM - 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: 18326467
• MDR Text Key: 330497938
• Report Number: 3008881809-2023-00581
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: 03/27/2023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FD50040
• Device Lot Number: 24253228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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
• Treatment: EXCELSIOR XT-27 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).