MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32515

Device Problem Difficult to Remove (1528)

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

Event Date 09/02/2020

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 device was returned with an xt-27 micro catheter and a second surpass evolve flow diverter system.The reported lot number was confirmed from the returned packaging.On visual inspection, the surpass evolve flow diverter stent was inspected and one of the ends was slightly frayed.The sdw was inspected and no anomaly was noted.The xt-27 micro catheter shaft was inspected and the distal end was flattened/crushed.Functional testing was not performed as the micro catheter shaft was deformed and the stent had already been deployed it was not possible to re sheath the stent.The reported event was confirmed during the device analysis.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and the device was prepared/set up as per the directions for use.Continuous flush was maintained for the duration of the procedure.The introducer sheath was properly inserted all the way into the micro catheter prior to transfer, while the introducer sheath was seated at the hub, the rhv was opened enough to allow passage of the device through without damage, when advancing the coil within the xt-27 micro catheter, the rhv was opened enough to allow passage of the device through without damage, excessive force was not applied at any point while advancing the coil within the micro catheter and the patient¿s anatomy was mildly tortuous.As the device would not re-sheath, it was discarded a new device and xt-27 micro catheter were used to finish the procedure.There was a surgical delay of 10 minutes as a new device and micro catheter had to be opened and replaced the device which would not re sheath.Based on the event description it appears the physician was attempting to recapture the stent back into the micro catheter during deployment in the patient.Product analysis found the stent had been deployed from the surpass evolve flow diverter system.This indicates the stent had been deployed too far out of the micro catheter to allow the stent to be re-captured, i.E.The re sheath marker had been advanced beyond the micro catheter marker band, which is effectively a full deployment and the re-sheath pad is no longer effective at this point, and re-capture is not possible.An xt-27 micro catheter was returned with the fds.The xt-27 micro catheter shaft was found to be flattened/crushed at the distal end which would have prevented the stent from being recaptured.There was some deformation noted to end of the stent which most likely occurred as a result of attempting to recapture the stent back into the deformed micro catheter shaft.An assignable cause of ¿caused by other¿ will be assigned to the reported stent difficult/unable to pull stent back into sheath and to the analyzed stent deformed and flow diverter stent difficult/unable to re-capture into micro catheter as the investigation indicates another product/drug/subsequent procedure caused the issue event.

Event Description

It was reported that during the procedure, the physician was unable re sheath the subject stent while trying to deploy the subject stent inside the patient.The subject device was replaced, and procedure was completed without clinical consequence to the patient.Analysis of the device revealed that the subject flow diverting stent failed to recapture into the micro catheter; therefore, based on this information the event is deemed reportable.

• Brand Name: SURPASS EVOLVE 3.25MM X 15MM - 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: 11141057
• MDR Text Key: 231172317
• Report Number: 3008881809-2021-00020
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: FD32515
• Device Lot Number: 21949790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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
• Patient Age: 69 YR