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 02/29/2024

Event Type  malfunction  

Event Description

It was reported that during a medial artery stenosis procedure, after a pre-dilation with the balloon, the guidewire was used to bring the subject stent to the target stenotic vessel.Next, the operator attempted to deploy the stent, however the outer sheath could not be pulled at all, and the proximal part of the shaft got fractured.The subject stent was removed and replaced with another device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 1 of 2 reports (1st mdr) 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 device was returned together with another stent system.The stent was found to be in its pre- deployed state.The proximal part of the stent stabilizer was found to be broken/fractured.The stent delivery catheter was fond to be deformed.The stent delivery catheter was found to be kinked/bent in multiply areas.Significant amount of blood within the stent delivery catheter was noted.The stent was found to be intact.Functional inspection was not required as the reported event ¿stent stabilizer broken/fractured during use¿ was confirmed during visual inspection.The device was flushed.The stent could not be deployed due to significant friction caused by damaged stent delivery catheter.The stent was pulled out from the distal end.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.Both reported events were confirmed, and the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analysed 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 and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.It was reported that 'an attempt was made to insert the subject stent in combination with the guidewire to approach the target stenotic vessel and attempted stent deployment, but the outer sheath could not be pulled at all, and the proximal part of the shaft was damaged.Therefore, the system was removed and replaced with a new one in the same catalog number'.In the follow-up good faith effort (gfe) process it was answered on two (2) separate occasions that, during advancement or repositioning of the device, the inner body was advanced independently of the outer body.The subject stent dfu instructs that the only time you move the inner body independently of the outer body is immediately prior to stent deployment.Extract from stent dfu: 'loosen the delivery system outer body rotating hemostasis valve, and advance the delivery system inner body until the proximal radiopaque markerband bumper is just proximal to the stent.Tighten the outer body rotating hemostasis valve'.It is not clear from the available information if the stent stabilizer was advanced independently of the stent system outer body after the stent had traversed the lesion.This may have been a contributing factor to the reported complaint.The stent was returned for analysis in it's pre-deployed state.The stent delivery catheter was deformed and was also kinked/bent at several locations along its length.The stabilizer was noted to be broken/fractured at it's 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 significant friction was noted between the stent stabilizer and the delivery catheter.The stent was deployed by pulling it out from the distal end of the device 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 patients anatomy.It may also have been related to the deformed outer catheter.The reported events: ¿stent stabilizer/catheter friction' and 'stent stabilizer broken/fractured during use' and the as analysed events: ¿stent stabilizer broken/fractured during use¿, ¿stent delivery catheter kinked/bent¿, ¿stent delivery catheter deformed¿, ¿stent stabilizer/catheter friction¿ 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.

• 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: 18987639
• MDR Text Key: 338724076
• Report Number: 3008881809-2024-00128
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0300150
• Device Lot Number: 24400498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2023
• 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: CHIKAI GUIDEWIRE (NON-STRYKER); GATEWAY BALLOON CATHETER (STRYKER); LOADMASTER CATHETER (NON-STRYKER)