MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 4.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0400200

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/24/2023

Event Type  malfunction  

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 partially deployed.The stent delivery catheter was found to be kinked/bent.The proximal part of the stent stabilizer was found to be kinked/bent.The stent was found to be intact.Blood was noted within the catheter and on stent.An unknown guidewire was found stuck inside the stent stabilizer.During functional inspection the device was flushed.The stent delivery catheter could be advanced and retracted from the demo guide catheter without difficulties.The stent could be deployed; however, friction was noted between stent stabilizer and 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 reported events 'stent delivery catheter friction' and 'stent failed/unable to deploy' could not be duplicated during analysis.However, the analysis results are consistent with the reported event.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated 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 reported to be set up and maintained throughout the clinical procedure and the patient¿s anatomy was described as 'severely tortuosity'.It was reported that 'percutaneous transluminal angioplasty (pta) and stenting were performed for intracranial stenosis.After pre-dilation with the balloon catheter, the subject stent was delivered to the target site, although resistance was encountered due to severely tortuous anatomy.After that, attempted to push up the inner bumper and perform deployment, but both could not be performed because the catheter did not move at all.Repeated the operation several times with considerable force, but the situation remained the same'.Prior to deployment of stent, the inner body was not able to advance to the proximal part of the stent and there was difficulty reported in pulling back the outer body.The stent was returned partially deployed from the stent delivery catheter.The stent delivery catheter itself was kinked/bent.Once fully deployed, the stent was inspected and was undamaged.During deployment, friction was noted between the stabilizer (inner body) and the stent delivery catheter (outer body).The proximal end of the stent stabilizer was kinked/bent.Damage to the stabilizer resulted in the unspecified guidewire being stuck inside the stabilizer.The system was flushed and the stent delivery catheter (delivery catheter outer body) was advanced and retracted in a demonstration guide catheter without difficulty.The event description indicates there was resistance while attempting to position the subject device into it's final location.It is most likely that due to unknown procedural factors and the severely tortuous anatomy, the user experienced this reported resistance.Due to this resistance, the user repeatedly applied force to try and advance the device, resulting in the damage noted during analysis.The reported events 'stent delivery catheter friction' and 'stent failed/unable to deploy' and the analysed events ¿stent partial deployment¿, ¿stent stabilizer kinked/bent¿, ¿stent delivery catheter kinked/bent¿, ¿stent stabilizer/catheter friction¿ will be assigned procedural factors.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

The stent (subject device) was returned for analysis and the device investigation revealed that the that the stent was partially deployed.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: WINGSPAN 4.0MM X 20MM - 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: 18857797
• MDR Text Key: 337189355
• Report Number: 3008881809-2024-00097
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0400200
• Device Lot Number: 24361450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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: GATEWAY BALLOON CATHETER (STRYKER)