MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300150

Device Problem Fracture (1260)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that an endovascular surgical procedure was performed on a patient with eighty percent stenosis of left mca m1.During the procedure a guidewire was used to bring a balloon to dilate the target lesion.Later the subject stent was delivered to the target lesion, however when fixed the inner shaft and retracted the outer shaft to deploy the subject stent, the subject stent was not able to be pushed out of tip of microcatheter.It was noted that when attempted to be deploy the subject stent, the inner body proximal ro marker of the inner shaft was withdraw together with the outer shaft but the subject stent did not move.The physician retrieved the whole system and tried again to deliver and deploy the subject stent, but the subject stent was still not able to be deployed.The physician believed that the ro marker of the inner shaft of the subject stent delivery system was damaged.The subject stent was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the stent was found to be deployed and not returned.The proximal end of the stent stabilizer was found to be kinked/bent.The stent delivery catheter was found to be kinked/bent.The ro marker of inner body was found to be intact.There was not detachment/separation noted.Functional inspection: stent failed/unable to deploy functional test ¿ unable to perform as the stent was found to be deployed and not returned.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 stent failed/unable to deploy could not be confirmed during analysis as the stent was found to be deployed and not returned, however the damage to the device is indicative of the reported event.The reported ro marker detached/separated/not visible under fluoroscopy was not confirmed during the analysis.As per the additional information, the device prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The device was returned and both the stabilizer and delivery catheter ro markers were confirmed to be intact, therefore an assignable cause of not confirmed will be assigned to the reported ro marker(s) detached/separated/not visible under fluoroscopy.The delivery catheter and stabilizer were noted to be kinked and the stent had been deployed.It is probable that the stabilizer and delivery catheter were damaged during the clinical procedure causing the difficulty to deploy the stent and subsequent premature deployment.An assignable cause of procedural factors will be assigned to the reported stent failed/unable to deploy and to the analyzed stent delivery catheter kinked/bent, stent stabilizer kinked/bent, and stent deployed prematurely during use, 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.

Event Description

It was reported that an endovascular surgical procedure was performed on a patient with eighty percent stenosis of left mca m1.During the procedure a guidewire was used to bring a balloon to dilate the target lesion.Later the subject stent was delivered to the target lesion, however when fixed the inner shaft and retracted the outer shaft to deploy the subject stent, the subject stent was not able to be pushed out of tip of microcatheter.It was noted that when attempted to be deploy the subject stent, the inner body proximal ro marker of the inner shaft was withdraw together with the outer shaft but the subject stent did not move.The physician retrieved the whole system and tried again to deliver and deploy the subject stent, but the subject stent was still not able to be deployed.The physician believed that the ro marker of the inner shaft of the subject stent delivery system was damaged.The subject stent was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN 3.0MM X 15MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• 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: 13064418
• MDR Text Key: 284650484
• Report Number: 3008881809-2021-00544
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H050001
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Catalogue Number: M003WE0300150
• Device Lot Number: 22834262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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: ENVOY 6F GUIDE CATHETER (CODMAN NEURO); GATEWAY BALLOON HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF#(STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER)
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Asian