MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 2.5MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250200

Device Problem Premature Activation (1484)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

The subject device was returned for analysis and the device investigation revealed that the subject stent was found partially deployed and the subject stent stabilizer broken/fractured during use.The subject stent was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

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.During visual inspection, the stent stabilizer was found broken/fractured which the customer confirmed did not happen during the procedure.The stabilizer was found to be kinked/bent.The stent was found partially deployed and the stent delivery catheter was noted to be kinked/bent and flattened/crushed.During functional inspection, the stent delivery catheter could be advanced through and retrieved from a guide catheter without difficulties.The stent could not be deployed due to significant friction between stent stabilizer and stent delivery catheter.Due to the condition of the returned device, the reported friction between the stent stabilizer and the guidewire could not be performed.The reported event of stent delivery catheter friction was not confirmed during the analysis.The reported events stent stabilizer kinked/bent, stent failed/unable to deploy, stent stabilizer/catheter friction and stent stabilizer friction were confirmed during device analysis.The reported event of stent stabilizer/guidewire friction was not confirmed during device analysis.However, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed 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 procedure.The patients anatomy was described as 'severely tortuous' and the percentage stenosis and calcification at the lesion was 90%.It was reported that the customer 'delivered subject device to the lesion.When deploying the subject device, after the tip marker of stent was pushed out, the outer body of the stent delivery shaft could not be retracted any more.The operator pushed the inner body but the stent was still not able to be pushed any more with big resistance.During the procedure the proximal of the delivery pole was kinked, so the operator withdrew the stent system out'.Additionally, it was clarified that resistance/friction was noted between the stabilizer and the delivery catheter (outer body), when advancing the stent system over the guidewire and when advancing the stabilizer to its final position prior to deployment.When asked if the anatomy and/or location of the intended treatment may have contributed to the reported event, the physician answered 'yes'.Finally, it was clarified that the delivery pole in the event description refers to the stabilizer (inner body).This was originally kinked during the procedure but it was not fractured during the procedure.There was no as analysed code assigned to this defect.The stent was returned for analysis partially deployed.Once fully deployed it was noted to be undamaged.The stent stabilizer (delivery catheter inner body) was returned broken/fractured (not fractured during the procedure).It was also noted to be kinked/bent.The stent delivery catheter (delivery catheter outer body) was returned and was kinked/bent and also flattened/crushed.There was friction noted during the stent stabilizer friction functional test and the stent stabilizer/catheter friction functional test which is most likely due to the damage noted to the stent delivery catheter.This friction is the most likely reason why the stabilizer ended up being kinked/bent.The as reported events stent stabilizer kinked/bent, stent failed/unable to deploy, stent stabilizer/catheter friction, stent stabilizer/guidewire friction and stent stabilizer friction will be assigned as assignable cause of 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 product use.The as analyzed events of stent delivery catheter flat/crushed, stent delivery catheter kinked/bent, stent partial deployment, stent stabilizer kinked/bent, stent failed/unable to deploy, stent stabilizer/catheter friction and stent stabilizer 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 product use.The as reported event of stent delivery catheter friction will be assigned not confirmed as the issue was not confirmed during the analysis.

• Brand Name: WINGSPAN 2.5MM X 20MM - 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: 16029627
• MDR Text Key: 307979289
• Report Number: 3008881809-2022-00642
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Catalogue Number: M003WE0250200
• Device Lot Number: 21949067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian