MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 17MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32517

Device Problem Premature Activation (1484)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that during the mca bifurcation aneurysm treatment, when the physician tried to deploy the subject flow diverting stent but only the distal part of the delivery wire was coming out and resistance was felt in advancing the subject stent inside the microcatheter.The subject flow diverting stent dislodged from the re-sheath pad and deployed prematurely inside the microcatheter.Both the microcatheter and subject stent was retracted from the anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The subject device is not yet returned.

Event Description

It was reported that during the mca bifurcation aneurysm treatment, when the physician tried to deploy the subject flow diverting stent but only the distal part of the delivery wire was coming out and resistance was felt in advancing the subject stent inside the microcatheter.The subject flow diverting stent dislodged from the re-sheath pad and deployed prematurely inside the microcatheter.Both the microcatheter and subject stent was retracted from the anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the stent delivery wire was found to be kinked/bent.The stent was found to be deployed inside the catheter.The stent was found to be deformed and the introducer sheath was found to be intact.Functional testing was unable to perform as the stent was found to be deployed inside the microcatheter.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.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.Additional information provided by the customer indicated there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and the device was prepared for use as per the directions for use.Continuous flush was set up and maintained throughout the clinical procedure.Other catheter devices were used in the procedure in conjunction with the subject device, the device was not in use on the patient at the time of the event and the patient¿s anatomy was not tortuous.The issue occurred inside the patient.The issue with the catheter was as per physician there was slight friction while pushing the stent not sure what is the issue with catheter.There was no sheathing.The condition being treated and the anatomical location of the treatment site was mca bifurcation aneurysm treatment.There were no anomalies noted to the device prior to use, the stent delivery system was flushed with saline prior to use, the guide catheter rhv was adequately opened to allow insertion/ advancement of the stent delivery system, the guide catheter was flushed prior to insertion of the stent delivery system, the stent experienced slight friction when moving the system inside the catheter.The physician does not feel that the anatomy and/or location of intended area of treatment may have contributed to the reported event, the stent delivery system was able to be advanced to the lesion, the delivery catheter rhv was opened sufficiently to allow stent deployment, there was no difficulty pulling back the outer body.After removal, the physician did not attempt to deploy the stent on the table (outside the patient¿s body) as only the delivery wire was coming out of catheter then stent was deployed in the catheter itself.It is most likely that anatomical or procedural factors encountered during the procedure contributed to the reported event.An assignable cause of procedural factors will be assigned to the event of the stent deployed prematurely during use, the stent difficult/unable to advance or pullback through catheter and to the analyzed defects of the stent deformed and stent delivery wire kinked/bent as the issue is associated with a product that meets stryker 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.

• Brand Name: SURPASS EVOLVE 3.25MM X 17MM - 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: 13195053
• MDR Text Key: 286950612
• Report Number: 3008881809-2022-00006
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: FD32517
• Device Lot Number: 22481327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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: AXS CATALYST 5 (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); SURPASS EVOLVE FLOW DIVERTING STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: Asian