MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 25MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD45025

Device Problems Premature Activation (1484); Difficult to Remove (1528)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Other text : the device is not available to the manufacturer.

Event Description

It was reported that flow diverter implantation procedure was performed for the middle cerebral artery.The patient is reported to have a very tortuous anatomy and in the physician's opinion this could have been the cause of this event as the resistance was felt while advancement of the stent to the targeted lesion.The subject stent reached the target site, partially opened and could not be fully encapsulated.It was reported that there was three hours of surgical delay due to this event.The physician replaced it with a new device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was reported that after implanting the stent into a very tortuous anatomy, the stent reached the release site partially opened and couldn't be re-encapsulated.The additional information states that there was resistance to cross trough the very tortuous anatomy and there was difficulty pulling back the outer body.The device was not returned for analysis.It is probable that the tortuous nature of the patients anatomy caused the reported event.An assignable cause of procedural factors will be assigned to the reported event, as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

Event Description

It was reported that flow diverter implantation procedure was performed for the middle cerebral artery.The patient is reported to have a very tortuous anatomy and in the physician's opinion this could have been the cause of this event as the resistance was felt while advancement of the stent to the targeted lesion.The subject stent reached the target site, partially opened and could not be fully encapsulated.It was reported that there was three hours of surgical delay due to this event.The physician replaced it with a new device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 4.5MM X 25MM - 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: 12457467
• MDR Text Key: 271048188
• Report Number: 3008881809-2021-00373
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 01/16/2022

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: 11/18/2021
• Device Catalogue Number: FD45025
• Device Lot Number: 2591221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• Treatment: CATALYST 5 DISTAL ACCESS CATHETER (STRYKER).; EXCELSIOR XT-27 MICROCATHETER (STRYKER).; INFINITY LONG SHEATH (STRYKER).
• Patient Age: 48 YR
• Patient Sex: Male