MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD45020

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that during the procedure, flow diverter (subject device) partially deployed but it did not detach completely. In order to refine the placement, the physician tried to insert the subject flow diverter into the microcatheter, but it could only be retracted halfway with no way to go further. The physician was forced to pull the carrier microcatheter up over the whole thing to protect the partially deployed subject flow diverter that was halfway out. The physician removed it safely and successfully from the patient's anatomy. The procedure was completed successfully. No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 12376204
• MDR Text Key: 268448625
• Report Number: 3008881809-2021-00349
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/12/2022
• Device Catalogue Number: FD45020
• Device Lot Number: 21862561R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/27/2021 Patient Sequence Number: 1

Treatment

UNKNOWN MICROCATHETER