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

Catalog Number M003WE0450200

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

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 was found in its deployed state and noted to be deformed.The distal 15cm section of the delivery catheter was noted to be flattened in a number of locations and the distal end of the stabilizer was extended 25mm end of the delivery catheter.During visual inspection, the delivery catheter was flushed, and a lot of blood exited.The stabilizer moved with resistance through the delivery catheter and the distal taper tip was cut to attempt to remove the stabilizer from the delivery catheter; however, the stabilizer was unable to be removed due to high resistance.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.As per the additional information, the patient¿s anatomy was averagely tortuous.The device was returned, and the stent had been deployed.There was a lot of blood noted within the delivery catheter, which is an indication of insufficient flush.The blood within the derive coupled with the damage noted to the device caused friction while the stabilizer moved within the delivery catheter during analysis.It is probable that the device was damaged during navigation to the target lesion causing the reported friction during use.An assignable cause of procedural factors will be assigned to the reported issue stent delivery catheter friction and to the as analyzed issues, 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.This is the second of 2 reports.

Event Description

Analysis of the returned device found that the subject stent deployed premature during use.There were no adverse consequences reported to the patient as a result of the reported event.

• Brand Name: WINGSPAN STENT SYSTEM 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 ; 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: 10307952
• MDR Text Key: 199921178
• Report Number: 3008881809-2020-00215
• 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: 07/21/2020

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: 06/04/2022
• Device Catalogue Number: M003WE0450200
• Device Lot Number: 21464190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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: 3 WINGSPAN STENT SYSTEM (STRYKER)