MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 4.5MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0450200

Device Problem Fracture (1260)

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

Event Date 12/25/2023

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 returned in its pre-deployed state.The stent stabilizer was found to be kinked/bent.The stent stabilizer was found to be broken/fractured.The stent delivery catheter was found to be flattened/crushed in multiply areas.The stent was found to be intact.During functional inspection to test the reported events: ¿stent failed/unable to deploy¿ and ¿stent stabilizer/catheter friction¿, the subject stent could be deployed; however, friction was noted between stent delivery catheter and stent stabilizer.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 event 'stent stabilizer/catheter friction' was confirmed during analysis.The second reported event 'stent failed/unable to deploy' could not be duplicated during functional analysis.However, 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 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 set up and maintained and the tortuosity of the patient¿s anatomy was described as 'severely tortuous'.It was reported that 'the stenosis site was fully dilated with the balloon, and an attempt was made to insert the subject stent; however, the inner body did not move at all, and the stent could not be deployed.The preparation was performed again, but still could not deploy the stent'.In the follow-up good faith effort (gfe) replies the user clarified that prior to deployment of the stent, the inner body was not able to advance to the proximal part of the stent.There was no resistance in advancing the stent system within the guiding catheter and the correct guidewire was used (recommended using a guidewire with an outer diameter (od) of 0.014".It is also recommended that the guide catheter have an internal diameter (id) of 0.064").In this instance the catheter was used with an id of 0.080".The stent was returned for analysis in its pre-deployed state.The stent delivery catheter was flattened/crushed at multiple locations along its length.The stabilizer was kinked/bent and was also noted to be broken/fractured at its proximal end with the molded rotating hemostatic valve (rhv) missing from the proximal end of the stabilizer.During functional testing, an attempt was made to advance the stent, and friction was noted between the stent stabilizer and the delivery catheter.The stent was successfully deployed and was noted to be undamaged upon inspection.Damage to the stabilizer most likely occurred due to the difficulty experienced when attempting to deploy the stent.It is not clear why there was an initial issue deploying the stent, but it is most likely that it was due to the severe tortuosity of the patient¿s anatomy.It may also have been related to the flattened outer catheter.The reported events: ¿stent failed/unable to deploy' and 'stent stabilizer/catheter friction' as well as the analyzed events: ¿stent stabilizer kinked/bent¿, ¿stent delivery catheter flat/crushed¿, ¿stent stabilizer/catheter friction¿, ¿stent stabilizer broken/fractured during use¿ will be assigned procedural factors as 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 subject stent was returned for analysis and the device investigation revealed that the subject stent stabilizer was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN 4.5MM 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: 19004814
• MDR Text Key: 339118760
• Report Number: 3008881809-2024-00132
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0450200
• Device Lot Number: 24400510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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: AXCELGUIDE GUIDE CATHETER (NON-STRYKER); GATEWAY BALLOON CATHETER (STRYKER); SYNCHRO SUPPORT GUIDEWIRE (STRYKER)