MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0350150

Device Problem Premature Activation (1484)

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

Event Date 03/10/2024

Event Type  Injury  

Event Description

It was reported that during middle cerebral artery (mca) stenosis procedure, the operator delivered the subject stent.However, when the subject stent reached c6 segment, it deployed prematurely.The operator used a snare device to remove the subject stent from the patient's anatomy.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during middle cerebral artery (mca) stenosis procedure, the operator delivered the subject stent.However, when the subject stent reached c6 segment, it deployed prematurely.The operator used a snare device to remove the subject stent from the patient's anatomy.The subject device 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 manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the stent was found to be deployed.The stent was found to be deformed and broken/fractured.One of the ro markers was found to be missing due to breakage.The stent delivery catheter was found to be kinked/bent in multiply areas.The stent stabilizer was found to be kinked/bent in multiply areas.Functional inspection to test the reported event ¿stent deployed prematurely during use¿ was not performed as the subject stent was returned in deployed state.During functional inspection to test the reported event ¿stent delivery catheter friction¿, the stent delivery catheter was advanced through the demo guide catheter.The friction was noted in the damaged areas of the stent delivery catheter.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 as reported events 'stent deployed prematurely during use' and 'stent delivery catheter friction' were both confirmed during analysis.The analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicate that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained and the tortuosity of the patient¿s anatomy was described as 'moderately tortuous'.It was reported that 'after using a balloon to dilate, the operator delivered the stent.When it reached c6 segment, the stent deployed prematurely.The operator then used snare device to catch it out of patient's body and then used another stent to deliver and deployed successfully to finish the procedure'.It was further reported in the follow-up good faith effort (gfe) process that the there was no friction noted when moving the stent system over the guidewire and no resistance advancing the stent system and guide catheter towards the lesion.However, the stent delivery system never reached the lesion as it prematurely deployed prior to this.The percentage stenosis was 90% and the level of calcification was unknown.It was further reported that there was difficulty experienced pulling back the outer body.This must refer to pulling back the outer body and inner stabilizer together as the stent did not reach the lesion.Therefore, there would have been no reason to pull back the outer body independently of the inner body.It is recommended in the subject stent dfu that the guide catheter have a minimum 90cm length and internal diameter (id) of 0.064".However, in this instance a catheter was used with a length of 115cm and id of 0.058".The use of a guide catheter with an id smaller than the recommended diameter could have been a factor involved in this complaint.The stent was returned for analysis in a deployed condition.The stent was noted to be deformed and it was also broken/fractured.One of the 4 marker bands was not present on one end of the stent.The stent delivery catheter was kinked/bent at multiple locations along it's length.The stabilizer (delivery system inner body) was also kinked/bent at multiple points along its length.During functional testing using a demonstration guide catheter, there was significant friction noted between the delivery catheter and the guide catheter.The use of a guide catheter with an inner diameter (0.058") smaller than the recommended internal diameter needed for advancing the subject stent system (of 0.064") is likely to have been a significant contributing factor leading to this complaint.An assignable cause of use error has been assigned to the reported events: 'stent deployed prematurely during use' and 'stent delivery catheter friction' and the analyzed events: ¿stent delivery catheter friction¿, ¿stent deployed prematurely during use¿, ¿stent broken/fractured during use¿, ¿stent deformed¿, ¿stent delivery catheter kinked/bent¿, ¿stent stabilizer kinked/bent¿, 'ro marker missing'.This complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications.However, there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

• Brand Name: WINGSPAN 3.5MM 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: 19000845
• MDR Text Key: 338880432
• Report Number: 3008881809-2024-00131
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0350150
• Device Lot Number: 24187020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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: CAT 5 CATHETER (STRYKER); SNARE DEVICE (UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Race: Asian