MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 2.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250150

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the delivery catheter was damaged and the stent was not returned.During the functional inspection the catheter was hydrated, and the coating was tested with wet fingers.The catheter shaft was damaged and the stent stabilizer was kinked/bent.An attempt was made to advance/ remove the stabilizer, however it was unable to be removed due to the deformation noted to the delivery catheter.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned for analysis and the reported complaint was confirmed based on the damage noted to the device during analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.As per the additional information the patients anatomy was very tortuous.The device damage noted is indicative of the reported event.It is probable that the device was damaged during navigation through the tortuous anatomy causing the subsequent failure to deploy the stent.An assignable cause of procedural factors will be assigned to the reported event, 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

The device was returned for analysis and the investigation of the device revealed that the stent (subject device) prematurely deployed inside the patient.The stent delivery catheter was deformed, kinked and bent.There was friction noted between the stent stabilizer and the catheter used during investigation.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN STENT SYSTEM 2.5MM X 15MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 10236639
• MDR Text Key: 197833569
• Report Number: 3008881809-2020-00194
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JP
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: M003WE0250150
• Device Lot Number: 21069133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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