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

Catalog Number M003WE0350200

Device Problem Fracture (1260)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the stent stabilizer was found to be broken/fractured at the proximal end.The stent delivery catheter was found to be intact.The stent was found to be intact.During functional inspection, the stent failed/unable to deploy and stent friction functional test was passed.The device was flushed, and the stent was deployed without difficulties.No friction noted.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 reported codes stent friction and stent failed/unable to deploy were not confirmed during device analysis.The device did not meet specifications when received for complaint investigation based on visual inspection.Additional information received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patients anatomy was described as 'moderately tortuous'.The device was returned and the proximal end of the stent stabilizer was found to be broken/fractured.Functional testing was performed and there was no resistance noted and the stent was able to be deployed without difficulties.It is probable that the moderately tortuous anatomy may have caused the damage noted to the device and reported events during use.An assignable cause of procedural factors will be assigned to the stent friction and stent failed/unable to deploy, and to the as analyzed stent stabilizer broken/fractured during use, 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.

Event Description

Analysis of the returned device found that the proximal end of the subject stent stabilizer was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: WINGSPAN 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 ; 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: 15786951
• MDR Text Key: 307588049
• Report Number: 3008881809-2022-00566
• 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: 11/14/2022

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 Catalogue Number: M003WE0350200
• Device Lot Number: 23337480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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: TRANSEND GUIDEWIRE (STRYKER).
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: Asian