MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 2.5MM X 9MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250090

Device Problem Premature Activation (1484)

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

Event Date 06/11/2020

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.There was no packaging returned with the device, therefore it cannot be confirmed that the correct device was returned.On visual inspection, the stent was returned in its deployed state, with no anomalies noted.There was a kink to the delivery catheter shaft at 20cm from the distal end.The distal taper tip of the stabilizer was kinked.On functional testing, the delivery catheter was hydrated and there was some friction while advancing & retracting the stabilizer.The distal taper tip was cut off in order to remove and analyze the stabilizer and catheter id.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.As per the additional information the patients anatomy was severely tortuous.The device was returned for analysis and the damage noted is indicative of the reported event.It is probable that the device was damaged due to the friction experienced during navigation through the patients anatomy causing the reported event and the damage noted to the returned device.An assignable cause of procedural factors will be assigned to the reported stent failed/unable to deploy and to the analyzed stent deployed prematurely during use, stent delivery catheter kinked/bent, stent stabilizer kinked/bent and stent stabilizer/catheter friction, 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

It was reported that during the procedure, the subject stent was delivered to the lesion and prepared to deploy.However when deploying, resistance was encountered and the subject stent was unable to be deployed.After several tries the physician removed it from the patient's anatomy and replaced it with another stent without any clinical consequences to the patient due to this event.The subject stent was returned for analysis and it was discovered that the stent deployed prematurely during use.

• Brand Name: WINGSPAN 2.5MM X 9MM - 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: 10627676
• MDR Text Key: 209815145
• Report Number: 3008881809-2020-00282
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Catalogue Number: M003WE0250090
• Device Lot Number: 21191805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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: GATEWAY BALLOON (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
• Patient Age: 73 YR
• Patient Weight: 67