MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.5MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0350200

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2020

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent has been completely deployed (outside patient after use), there were no anomalies noted to the deployed stent.The proximal 8.5cm section of the stabilizer had been broken and fractured.There was evidence of flattening to the distal 20cm section of the delivery catheter.The stabilizer was kinked at 3cm from the distal end.During functional inspection, the delivery catheter was flushed, and the stabilizer moved freely within, the distal taper tip was cut off in order to remove the stabilizer and it was removed without difficulty.There was a further kink noted to the stabilizer at 31cm from the proximal end.The reported issue is covered in the device directions for use (dfu).As well, the risk of the reported issue is documented in the risk documentation and there are current controls to mitigate the risk of the reported issue.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 patient¿s anatomy was severely tortuous.During analysis, the damage noted to the device is indicative of the reported event.It is probable that the device was damaged during navigation through the tortuosity anatomy causing the subsequent failure to deploy the stent.An assignable cause of procedural factors will be assigned to the reported and to the analyzed events, as the issue is associated with a product that meets 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 stent (subject device) was returned for analysis and based on the investigation, it was discovered that the proximal section of the stent stabilizer had been broken and fractured during the procedure.The distal section of the delivery catheter was found flattened and the stabilizer was kinked at the distal end.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

The stent (subject device) was returned for analysis and based on the investigation, it was discovered that the proximal section of the stent stabilizer had been broken and fractured during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN STENT SYSTEM 3.5MM X 20MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10286145
• MDR Text Key: 199689680
• Report Number: 3008881809-2020-00212
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: 06/24/2022
• Device Catalogue Number: M003WE0350200
• Device Lot Number: 21549335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT-27 MICROCATHETER (STRYKER); GATEWAY BALLOON CATHETER (STRYKER); NEUROFORM STENT (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER)
• Patient Age: 70 YR
• Patient Weight: 76